iCaReMe 全球注册 (iCaReMe)
2026年9月7日 更新者:AstraZeneca
确定 2 型糖尿病、高血压、心力衰竭和/或慢性肾脏病患者的管理和护理质量的真实世界跨国注册
提供有关 2 型糖尿病、高血压、心力衰竭和/或慢性肾病患者特征、疾病管理、医疗保健利用和结果的真实世界数据
研究概览
详细说明
该登记处旨在为许多国家的临床实践中的 T2DM、高血压、热衰竭和慢性肾病患者提供有关患者管理和护理质量的真实世界数据。
为了弥合这一差距,建立了一项观察性自愿登记,以获取有关患者特征、疾病管理、医疗保健利用以及 2 型糖尿病、高血压、心力衰竭和慢性肾脏病患者结果的真实世界数据。
使用基于云的 eCRF 的跨国观察登记,用于前瞻性和回顾性数据收集,研究人员和科学委员会可以访问。
该登记处将向全世界管理 T2DM、HTN、HF 或 CKD 的所有医生开放。
研究类型
观察性的
注册 (估计的)
35000
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:AstraZeneca Clinical Study Information Center
- 电话号码:1-877-240-9479
- 邮箱:information.center@astrazeneca.com
学习地点
-
-
Dnipropetrovsk Oblast
-
Dnipro、Dnipropetrovsk Oblast、乌克兰、49005
- 招聘中
- Research Site
-
-
Kharkiv Oblast
-
Kharkiv、Kharkiv Oblast、乌克兰、61039
- 招聘中
- Research Site
-
Kharkiv、Kharkiv Oblast、乌克兰
- 招聘中
- Research Site
-
-
Kyiv Oblast
-
Kyiv、Kyiv Oblast、乌克兰、3039
- 招聘中
- Research Site
-
Kyiv、Kyiv Oblast、乌克兰、4050
- 招聘中
- Research Site
-
-
Vinnytsia Oblast
-
Vinnytsia、Vinnytsia Oblast、乌克兰、21000
- 招聘中
- Research Site
-
-
Volyn Oblast
-
Lutsk、Volyn Oblast、乌克兰、43024
- 招聘中
- Research Site
-
-
Zakarpattia Oblast
-
Uzhhorod、Zakarpattia Oblast、乌克兰、88000
- 招聘中
- Research Site
-
-
Zaporizhzhia Oblast
-
Zaporizhzhya、Zaporizhzhia Oblast、乌克兰、69035
- 招聘中
- Research Site
-
-
-
-
-
Tbilisi、乔治亚州
- 招聘中
- Research Site
-
-
-
-
-
Sulaymaniyah、伊拉克、46001
- 招聘中
- Research Site
-
-
-
-
-
Kumasi、加纳
- 招聘中
- Research Site
-
-
-
-
-
Florida、南非、1794
- 招聘中
- Research Site
-
Parow、南非、7505
- 招聘中
- Research Site
-
Umhlanga、南非、4320
- 招聘中
- Research Site
-
Umhlanga、南非、4319
- 招聘中
- Research Site
-
-
-
-
-
Ahmedabad、印度
- 招聘中
- Research Site
-
Kolkata、印度、700034
- 招聘中
- Research Site
-
Mumbai、印度、400006
- 招聘中
- Research Site
-
-
-
-
-
Changhua、台湾、500209
- 招聘中
- Research Site
-
Kaohsiung City、台湾、81301
- 招聘中
- Research Site
-
Niaosong、台湾、83301
- 招聘中
- Research Site
-
Taichung、台湾、40447
- 招聘中
- Research Site
-
Taichung、台湾、40705
- 招聘中
- Research Site
-
Taichung、台湾
- 招聘中
- Research Site
-
Tainan、台湾、704
- 招聘中
- Research Site
-
Taipei、台湾
- 招聘中
- Research Site
-
Taoyuan City、台湾、33305
- 招聘中
- Research Site
-
-
-
-
-
Aktobe、哈萨克斯坦、30019
- 招聘中
- Research Site
-
Almaty、哈萨克斯坦、50000
- 招聘中
- Research Site
-
Almaty、哈萨克斯坦、50006
- 招聘中
- Research Site
-
Almaty、哈萨克斯坦、50012
- 招聘中
- Research Site
-
Almaty、哈萨克斯坦、50054
- 招聘中
- Research Site
-
-
-
-
-
San José、哥斯达黎加
- 招聘中
- Research Site
-
-
-
-
-
Alexandria、埃及
- 招聘中
- Research Site
-
Cairo、埃及
- 招聘中
- Research Site
-
Giza、埃及
- 招聘中
- Research Site
-
-
-
-
-
Iztapalapa、墨西哥
- 招聘中
- Research Site
-
Mexico City、墨西哥、06720
- 招聘中
- Research Site
-
Mexico City、墨西哥
- 招聘中
- Research Site
-
México、墨西哥、04530
- 招聘中
- Research Site
-
-
Guanajuato
-
León、Guanajuato、墨西哥、37549
- 招聘中
- Research Site
-
-
-
-
-
Enugu、尼日利亚、400001
- 招聘中
- Research Site
-
Gwagwalada、尼日利亚、901002
- 招聘中
- Research Site
-
Kano、尼日利亚、700233
- 招聘中
- Research Site
-
-
-
-
-
São Paulo、巴西、05403-000
- 招聘中
- Research Site
-
São Paulo、巴西、05403-900
- 招聘中
- Research Site
-
-
Ceará
-
Fortaleza、Ceará、巴西、60840-285
- 招聘中
- Research Site
-
-
Espírito Santo (ES)
-
Colatina、Espírito Santo (ES)、巴西、29707-035
- 招聘中
- Research Site
-
-
Estado de Bahia
-
Salvador、Estado de Bahia、巴西、40730-220
- 招聘中
- Research Site
-
-
Federal District
-
Brasília、Federal District、巴西、70673-623
- 招聘中
- Research Site
-
-
Minas Gerais
-
Poços de Caldas、Minas Gerais、巴西、37706-106
- 招聘中
- Research Site
-
-
Paraná
-
Campina Grande do Sul、Paraná、巴西、83430-000
- 招聘中
- Research Site
-
Curitiba、Paraná、巴西、80230-020
- 招聘中
- Research Site
-
-
Piauí (PI)
-
Teresina、Piauí (PI)、巴西、64001-450
- 招聘中
- Research Site
-
-
Rio Grande Do Sul (RS)
-
Santa Cruz do Sul、Rio Grande Do Sul (RS)、巴西、96835-090
- 招聘中
- Research Site
-
-
State of Goias
-
Goiânia、State of Goias、巴西、74453-200
- 招聘中
- Research Site
-
-
State of Santa Catarina
-
Joinville、State of Santa Catarina、巴西、89204-248
- 招聘中
- Research Site
-
-
São Paulo
-
Bragança Paulista、São Paulo、巴西、12916-542
- 招聘中
- Research Site
-
São Caetano do Sul、São Paulo、巴西、09521-160
- 招聘中
- Research Site
-
-
-
-
Santiago Metropolitan
-
Providencia、Santiago Metropolitan、智利、7500922
- 招聘中
- Research Site
-
-
-
-
-
Abidjan、科特迪瓦
- 招聘中
- Research Site
-
-
-
-
-
Nairobi、肯尼亚、14497
- 招聘中
- Research Site
-
-
-
-
-
Bulacan、菲律宾
- 尚未招聘
- Research Site
-
Cebu City、菲律宾
- 招聘中
- Research Site
-
Iloilo City、菲律宾
- 尚未招聘
- Research Site
-
Laguna、菲律宾
- 尚未招聘
- Research Site
-
Mandaluyong、菲律宾
- 尚未招聘
- Research Site
-
Manila、菲律宾
- 尚未招聘
- Research Site
-
Mindoro、菲律宾
- 尚未招聘
- Research Site
-
Pampanga、菲律宾
- 尚未招聘
- Research Site
-
Quezon City、菲律宾
- 尚未招聘
- Research Site
-
Zamboanga City、菲律宾
- 尚未招聘
- Research Site
-
-
-
-
-
Sharjah city、阿拉伯联合酋长国
- 招聘中
- Research Site
-
-
-
-
-
Wan Chai、香港
- 招聘中
- Research Site
-
-
-
-
-
Kuala Lumpur、马来西亚
- 招聘中
- Research Site
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
取样方法
非概率样本
研究人群
患有 2 型糖尿病、高血压、心力衰竭和/或慢性肾病的成年人
描述
纳入标准:
- 年满 18 岁
- 患有 2 型糖尿病、高血压、心力衰竭和/或慢性肾病
- 提供参与注册表的书面知情同意书
排除标准:
- 患有危及生命的合并症且预期寿命低于 1 年
- 参与需要知情同意的干预试验
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:其他
- 时间观点:预期
队列和干预
团体/队列 |
|---|
|
T2DM Cohort
Patients with T2DM as enrollment motif or T2DM as comorbidity
|
|
HTN Cohort
Patients with HTN as enrollment motif or HTN as comorbidity
|
|
CKD Cohort
Patients with CKD as enrollment motif or CKD as comorbidity
|
|
HF Cohort
Patients with HF as enrollment motif or HF as comorbidity
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1. Age of particpants
大体时间:At Baseline
|
Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
|
At Baseline
|
|
2. Percentage of Participants by Sex
大体时间:At baseline
|
Distribution of participants by sex (male/female) reported as counts and percentages.
|
At baseline
|
|
3. Percentage of Participants by Ethnicity
大体时间:At Baseline
|
Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
|
At Baseline
|
|
4. Percentage of Participants by Education Level
大体时间:At Baseline
|
Distribution of participants by education level reported as counts and percentages for each education category.
|
At Baseline
|
|
5. Percentage of Participants by Marital Status
大体时间:At Baseline
|
Distribution of participants by marital status reported as counts and percentages for each marital status category.
|
At Baseline
|
|
6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease
大体时间:At Baseline
|
Percentage of participants with a family history of cardiovascular, renal, or metabolic (CVRM) disease (yes/no) reported as counts and percentages.
|
At Baseline
|
|
7.Percentage of Participants by Physical Activity Level
大体时间:At Baseline
|
Distribution of participants by physical activity level category reported as counts and percentages.
|
At Baseline
|
|
8. Percentage of Participants by Smoking Status
大体时间:At Baseline
|
Distribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.
|
At Baseline
|
|
9. Percentage of Participants by Alcohol Consumption
大体时间:At Baseline
|
Distribution of participants by alcohol consumption category reported as counts and percentages.
|
At Baseline
|
|
10. Body Weight of Participants
大体时间:At Baseline
|
Body weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
|
At Baseline
|
|
11. Height of Participants
大体时间:At Baseline
|
Height of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).
|
At Baseline
|
|
12. Body Mass Index (BMI) of Participants
大体时间:At Baseline
|
Body mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
|
At Baseline
|
|
13. Waist Circumference of Participants
大体时间:At Baseline
|
Waist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
|
At Baseline
|
|
14. Waist-to-Hip Ratio of Participants
大体时间:At Baseline
|
Waist-to-hip ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
|
At Baseline
|
|
15. Waist-to-Height Ratio of Participants
大体时间:At Baseline
|
Waist-to-height ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
|
At Baseline
|
|
16. Percentage of Participants by Cardiac and Renal Functional Measurements Category
大体时间:At Baseline
|
Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
|
At Baseline
|
|
17. Primary Disease Duration
大体时间:At Baseline
|
Duration of primary disease (T2DM, HTN, HF, or CKD) from initial diagnosis to enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
|
At Baseline
|
|
18. Percentage of Participants by Number and Types of Comorbidities
大体时间:At Baseline
|
Distribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.
|
At Baseline
|
|
19. Percentage of Participants by NYHA Functional Class
大体时间:At Baseline
|
Distribution of heart failure participants by New York Heart Association (NYHA) functional class (I, II, III, IV) reported as counts and percentages.
|
At Baseline
|
|
20. Percentage of Participants by Heart Failure Phenotype
大体时间:At Baseline
|
Distribution of heart failure participants by phenotype (HFrEF: ejection fraction ≤40%, HFmrEF: 41-49%, HFpEF: ≥50%) reported as counts and percentages.
|
At Baseline
|
|
21. Percentage of Participants by Heart Failure Etiology
大体时间:At Baseline
|
Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
|
At Baseline
|
|
22. Percentage of Participants by CKD Etiology
大体时间:At Baseline
|
Distribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.
|
At Baseline
|
|
23. Percentage of Participants by Hypertension Stage
大体时间:At Baseline
|
Distribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.
|
At Baseline
|
|
24. Percentage of Participants by Secondary Hypertension Etiology
大体时间:At Baseline
|
Distribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.
|
At Baseline
|
|
25. Office Systolic and Diastolic Blood Pressure
大体时间:At Baseline
|
Office blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
|
At Baseline
|
|
26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values
大体时间:At Baseline
|
Home blood pressure monitoring (HBPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
|
At Baseline
|
|
27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values
大体时间:At Baseline
|
Ambulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
|
At Baseline
|
|
28. Blood HbA1c
大体时间:Average of 3 years
|
HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
|
Average of 3 years
|
|
29. Fasting Glucose
大体时间:Average of 3 years
|
Fasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
|
Average of 3 years
|
|
30. Lipid Profile Testing
大体时间:Average of 3 years
|
Total cholesterol, LDL-C, HDL-C, triglycerides reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
|
Average of 3 years
|
|
31. Serum Creatinine
大体时间:Average of 3 years
|
Serum creatinine value reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
|
Average of 3 years
|
|
32. Estimated Glomerular Filtration Rate (eGFR)
大体时间:Average of 3 years
|
Estimated glomerular filtration rate (eGFR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mL/min/1.73m².
|
Average of 3 years
|
|
33. Urine Albumin-to-Creatinine Ratio (UACR)
大体时间:Average of 3 years
|
Urine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.
|
Average of 3 years
|
|
34. Serum Electrolyte Values
大体时间:Avergae of 3 years
|
Serum electrolyte values (sodium, potassium, chloride, bicarbonate) reported individually as mean ± standard deviation (SD) and median with interquartile range (IQR) in mmol/L.
|
Avergae of 3 years
|
|
35. Frequency of HbA1c Testing
大体时间:Average of 3 years
|
Frequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
|
36. Frequency of Fasting Glucose Testing
大体时间:Average of 3 years
|
Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
|
37. Frequency of Lipid Profile Testing
大体时间:Average of 3 years
|
Frequency of lipid profile testing (total cholesterol, LDL-C, HDL-C, triglycerides) reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
|
38. Frequency of Serum Creatinine Testing
大体时间:Average of 3 years
|
Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
|
39. Frequency of eGFR Assessment
大体时间:Average of 3 years
|
Frequency of estimated glomerular filtration rate (eGFR) assessment reported as counts and percentages of participants assessed per monitoring period.
|
Average of 3 years
|
|
40. Frequency of Urine Albumin-to-Creatinine Ratio Testing
大体时间:Average of 3 years
|
Frequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.
|
Average of 3 years
|
|
41. Echocardiography
大体时间:Average of 3 years
|
Frequency of echocardiography abnormalities reported as counts and percentages
|
Average of 3 years
|
|
42. Electrocardiogram (ECG)
大体时间:Average of 3 years
|
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
|
Average of 3 years
|
|
43. Participants Receiving Dietary Modification Counseling
大体时间:Average of 3 years
|
Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
|
Average of 3 years
|
|
44. Participants Enrolled in Exercise Programs
大体时间:Average of 3 years
|
Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
|
Average of 3 years
|
|
45. Participants Receiving Weight Management Interventions
大体时间:Average of 3 years
|
Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.
|
Average of 3 years
|
|
46. Participants Receiving Smoking Cessation Counseling
大体时间:Average of 3 years
|
Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
|
Average of 3 years
|
|
47. Participants Receiving Alcohol Reduction Counseling
大体时间:Average of 3 years
|
Percentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.
|
Average of 3 years
|
|
48. Percentage of Participants by Line of Treatment
大体时间:Average of 3 years
|
Distribution of participants by line of pharmacological treatment (first-line, second-line, third-line or higher) reported as counts and percentages.
|
Average of 3 years
|
|
49. Percentage of Participants by Drug Class
大体时间:Average of 3 years
|
Distribution of participants by drug class prescribed (e.g., SGLT2i, GLP-1RA, ACEi, ARBs, beta-blockers, MRAs, CCBs, diuretics, metformin, DPP-4i, sulfonylureas, insulin) reported as counts and percentages.
|
Average of 3 years
|
|
50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)
大体时间:Average of 3 years
|
Percentage of participants undergoing coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) reported as counts and percentages for each procedure type.
|
Average of 3 years
|
|
51. Percentage of Participants Receiving Dialysis
大体时间:Average of 3 years
|
Percentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.
|
Average of 3 years
|
|
52. Percentage of Participants with Cardiac Device Implantation
大体时间:Average of 3 years
|
Percentage of participants with cardiac device implantation (pacemaker, implantable cardioverter-defibrillator [ICD], or cardiac resynchronization therapy [CRT]) reported as counts and percentages for each device type.
|
Average of 3 years
|
|
53. Mean Duration of Pharmacological Treatments
大体时间:Average of 3 years
|
Duration of pharmacological treatments reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in months for each drug class.
|
Average of 3 years
|
|
54. Drug Dose of Pharmacological Treatments
大体时间:Average of 3 years
|
Drug dose of pharmacological treatments prescribed reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in milligrams (mg) for each drug class.
|
Average of 3 years
|
|
55. Number of Primary Care Visits per Participant
大体时间:Average of 3 years
|
Total number of primary care visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
56. Number of Tertiary Care Hospital Visits per Participant
大体时间:Average of 3 years
|
Total number of tertiary care hospital visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
57. Number of Specialist Care Visits per Participant
大体时间:Average of 3 years
|
Total number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
58.Number of Emergency Department Visits per Participant
大体时间:Average of 3 years
|
Total number of emergency department visits reported as total visits and mean visits per participant ± standard deviation (SD).
|
Average of 3 years
|
|
59. All-Cause Hospitalizations
大体时间:Average of 3 years
|
All-cause hospitalizations reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
|
Average of 3 years
|
|
60. Disease-Specific Hospitalizations
大体时间:Average of 3 years
|
Disease-specific hospitalizations (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
|
Average of 3 years
|
|
61. All-Cause Emergency Department Visits
大体时间:Average of 3 years
|
All-cause emergency department visits reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
|
Average of 3 years
|
|
62. Disease-Specific Emergency Department Visits
大体时间:Average of 3 years
|
Disease-specific emergency department visits (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
|
Average of 3 years
|
|
63. Length of Hospital Stay
大体时间:Average of 3 years
|
Length of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.
|
Average of 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
大体时间:Average of 3 years
|
Hypoglycemic events defined as blood glucose <70 mg/dL (Level 1 - alert value) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
|
Average of 3 years
|
|
2.Incidence of Level 2 Hypoglycemic Events (Blood Glucose <54 mg/dL)
大体时间:Average of 3 years
|
Hypoglycemic events defined as blood glucose <54 mg/dL (Level 2 - clinically significant) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
|
Average of 3 years
|
|
3.Incidence of Level 3 Hypoglycemic Events (Requiring Third-Party Assistance)
大体时间:Average of 3 years
|
Severe hypoglycemic events requiring third-party assistance (Level 3) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
|
Average of 3 years
|
|
4.Incidence of Diabetic Ketoacidosis (DKA) Episodes
大体时间:Average of 3 years
|
Diabetic ketoacidosis (DKA) episodes reported as counts, percentages of participants with at least one episode, and total number of episodes.
|
Average of 3 years
|
|
5. Percentage of Participants with Uncontrolled Type 2 Diabetes (HbA1c ≥7%)
大体时间:Average of 3 years
|
Percentage of participants with uncontrolled type 2 diabetes mellitus defined as HbA1c ≥7% reported as counts and percentages.
|
Average of 3 years
|
|
6. Percentage of Participants with Uncontrolled Hypertension (BP ≥140/90 mmHg)
大体时间:Average of 3 years
|
Percentage of participants with uncontrolled hypertension defined as blood pressure ≥140/90 mmHg or ≥130/80 mmHg (per applicable guideline threshold) reported as counts and percentages.
|
Average of 3 years
|
|
7. Incidence of Retinopathy
大体时间:Average of 3 years
|
Incidence of retinopathy reported as counts, percentages of participants with new-onset retinopathy, and incidence per 100 person-years.
|
Average of 3 years
|
|
8. Incidence of Nephropathy
大体时间:Average of 3 years
|
Incidence of nephropathy reported as counts, percentages of participants with new-onset nephropathy, and incidence per 100 person-years.
|
Average of 3 years
|
|
9. Incidence of Neuropathy
大体时间:Average of 3 years
|
Incidence of neuropathy reported as counts, percentages of participants with new-onset neuropathy, and incidence per 100 person-years.
|
Average of 3 years
|
|
10. Incidence of Myocardial Infarction (MI)
大体时间:Average of 3 years
|
Incidence of myocardial infarction (MI) reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
|
Average of 3 years
|
|
11. Incidence of Stroke
大体时间:Average of 3 years
|
Incidence of stroke reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
|
Average of 3 years
|
|
12. Incidence of Peripheral Arterial Disease (PAD)
大体时间:Average of 3 years
|
Incidence of peripheral arterial disease (PAD) reported as counts, percentages of participants with new-onset PAD, and incidence per 100 person-years.
|
Average of 3 years
|
|
13. Incidence of Coronary Revascularization
大体时间:Average of 3 years
|
Incidence of coronary revascularization procedures reported as counts, percentages of participants undergoing revascularization, and incidence per 100 person-years.
|
Average of 3 years
|
|
14. Incidence of New-Onset Heart Failure
大体时间:Average of 3 years
|
Incidence of new-onset heart failure diagnosis reported as counts, percentages of participants with new HF diagnosis, and incidence per 100 person-years.
|
Average of 3 years
|
|
15. Incidence of New-Onset Chronic Kidney Disease
大体时间:Average of 3 years
|
Incidence of new-onset chronic kidney disease defined as eGFR <60 mL/min/1.73m²
or urine albumin-to-creatinine ratio (UACR) ≥30 mg/g reported as counts, percentages of participants, and incidence per 100 person-years.
|
Average of 3 years
|
|
16. Percentage of Participants Developing Anemia
大体时间:Average of 3 years
|
Percentage of participants developing anemia as a cardio-renal complication reported as counts and percentages.
|
Average of 3 years
|
|
17. Percentage of Participants Developing Hyperkalemia
大体时间:Average of 3 years
|
Percentage of participants developing hyperkalemia as a cardio-renal complication reported as counts and percentages.
|
Average of 3 years
|
|
18. Percentage of Participants with Heart Failure Hospitalization
大体时间:Average of 3 years
|
Percentage of participants with at least one heart failure hospitalization reported as counts and percentages.
|
Average of 3 years
|
|
19. Percentage of Participants with eGFR Decline
大体时间:Average of 3 years
|
Percentage of participants experiencing a clinically significant decline in estimated glomerular filtration rate (eGFR) reported as counts and percentages.
|
Average of 3 years
|
|
20. Percentage of Participants with RRT Initiation or ESRD Progression
大体时间:Average of 3 years
|
Percentage of participants initiating renal replacement therapy (RRT) or progressing to end-stage renal disease (ESRD) reported as counts and percentages.
|
Average of 3 years
|
|
21. Incidence of Renal Replacement Therapy Initiation or ESRD Progression
大体时间:Average of 3 years
|
Incidence of renal replacement therapy (RRT) initiation or progression to end-stage renal disease (ESRD) reported as counts, percentages of participants, and rate per 100 person-years.
|
Average of 3 years
|
|
22. Incidence of All-Cause Mortality
大体时间:Average of 3 years
|
All-cause mortality reported as counts, percentages of participants, and rate per 100 person-years.
|
Average of 3 years
|
|
23. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Incidence of Hypoglycemic Events
大体时间:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and incidence of hypoglycemic events.
|
Average of 3 years
|
|
24. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled T2DM
大体时间:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled T2DM (HbA1c ≥7%).
|
Average of 3 years
|
|
26. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled HTN
大体时间:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled HTN (BP ≥140/90 mmHg).
|
Average of 3 years
|
|
27. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Heart Failure Worsening
大体时间:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and heart failure worsening.
|
Average of 3 years
|
|
28. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and CKD Progression/RRT Initiation/ESRD Progression
大体时间:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and CKD Progression/RRT Initiation/ESRD Progression
|
Average of 3 years
|
|
29. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and All-cause mortality
大体时间:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and All-cause mortality
|
Average of 3 years
|
|
30. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and and Myocardial Infarction/Stroke/PAD
大体时间:Average of 3 years
|
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and Myocardial Infarction/Stroke/PAD
|
Average of 3 years
|
|
31. Correlation Between Patient Characteristics and Treatment Choices for T2DM
大体时间:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for T2DM (line of treatment and drug class: metformin, SGLT2i, GLP-1RA, DPP-4i, sulfonylureas, insulin).
|
Average of 3 years
|
|
32. Correlation Between Patient Characteristics and Treatment Choices for HTN
大体时间:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HTN (line of treatment and drug class: ACEi, ARBs, CCBs, beta-blockers, diuretics).
|
Average of 3 years
|
|
33. Correlation Between Patient Characteristics and Treatment Choices for HF
大体时间:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HF (line of treatment and drug class: ACEi, ARBs, ARNI, beta-blockers, MRAs, SGLT2i).
|
Average of 3 years
|
|
34. Correlation Between Patient Characteristics and Treatment Choices for CKD
大体时间:Average of 3 years
|
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for CKD (line of treatment and drug class: ACEi, ARBs, SGLT2i).
|
Average of 3 years
|
|
35. Percentage of Participants with Dyslipidemia by Category
大体时间:Average of 3 years
|
Distribution of participants with dyslipidemia by category reported as counts and percentages.
|
Average of 3 years
|
|
36. Percentage of Participants with Obesity by Category
大体时间:Average of 3 years
|
Distribution of participants with obesity by BMI category reported as counts and percentages.
|
Average of 3 years
|
|
37. Percentage of Participants Achieving LDL-C Target <100 mg/dL
大体时间:Average of 3 years
|
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <100 mg/dL reported as counts and percentages.
|
Average of 3 years
|
|
38. Percentage of Participants Achieving LDL-C Target <70 mg/dL
大体时间:Average of 3 years
|
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <70 mg/dL reported as counts and percentages.
|
Average of 3 years
|
|
40. Percentage of Participants Achieving Weight Loss ≥5%
大体时间:Average of 3 years
|
Percentage of participants achieving weight loss of 5% or more from baseline reported as counts and percentages.
|
Average of 3 years
|
|
41. Percentage of Participants Achieving Weight Loss ≥10%
大体时间:Average of 3 years
|
Percentage of participants achieving weight loss of 10% or more from baseline reported as counts and percentages.
|
Average of 3 years
|
|
42. Percentage of Participants Achieving Weight Loss ≥15%
大体时间:Average of 3 years
|
Percentage of participants achieving weight loss of 15% or more from baseline reported as counts and percentages.
|
Average of 3 years
|
|
43. Percentage of Participants Developing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
大体时间:Average of 3 years
|
Percentage of participants developing metabolic dysfunction-associated steatotic liver disease (MASLD) as an obesity complication reported as counts and percentages.
|
Average of 3 years
|
|
44. Percentage of Participants Developing T2DM as an Obesity Complication
大体时间:Average of 3 years
|
Percentage of participants developing new-onset type 2 diabetes mellitus (T2DM) as an obesity complication reported as counts and percentages.
|
Average of 3 years
|
|
45. Incidence of Myocardial Infarction/Stroke in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Incidence of myocardial infarction (MI)/stroke in participants with dyslipidemia and/or obesity reported as counts and percentages.
|
Average of 3 years
|
|
46. Lipid levels in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Total cholesterol, LDL-C, HDL-C, Triglyceride in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
|
Average of 3 years
|
|
47. Body Weight in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Body weight in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
|
Average of 3 years
|
|
48. BMI in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Body mass index (BMI) in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
|
Average of 3 years
|
|
49. Waist Circumference in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Waist circumference in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
|
Average of 3 years
|
|
50. Waist-to-Hip Ratio in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years through
|
Waist-to-hip ratio in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
|
Average of 3 years through
|
|
51. Frequency of Lipid Profile Monitoring in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Frequency of lipid profile testing in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
|
Average of 3 years
|
|
52. Frequency of Weight and BMI Monitoring in Participants with Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Frequency of weight and BMI measurements in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
|
Average of 3 years
|
|
53. Frequency of Obesity Complication Assessments
大体时间:Average of 3 years
|
Frequency of obesity complication assessments (screening for MASLD, T2DM, cardiovascular risk) reported as counts and percentages of participants assessed per clinical guidelines.
|
Average of 3 years
|
|
54. Percentage of Participants Receiving Lifestyle Modifications for Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Percentage of participants receiving lifestyle modification interventions (dietary, exercise, behavioral) for dyslipidemia and/or obesity management reported as counts and percentages.
|
Average of 3 years
|
|
55. Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
大体时间:Average of 3 years
|
Counts and Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
|
Average of 3 years
|
|
56. Percentage of Participants Undergoing Bariatric Surgery
大体时间:Average of 3 years
|
Percentage of participants undergoing bariatric surgery for obesity management reported as counts and percentages.
|
Average of 3 years
|
|
57. Mean Number of Visits for Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Number of visits for dyslipidemia and/or obesity management reported as counts and percentages of participants with at least one visit.
Visits for dyslipidemia and/or obesity management reported as mean ± standard deviation (SD) and total visits.
|
Average of 3 years
|
|
58. Percentage of Participants Hospitalized for Dyslipidemia/Obesity
大体时间:Average of 3 years
|
Percentage of participants with at least one hospitalization related to dyslipidemia and/or obesity reported as counts and percentages.
Hospitalizations for dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and total hospitalizations.
|
Average of 3 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任:Hardik Vasnawala, MD、AstraZeneca
- 研究主任:Isidro Villanueva, MD、AstraZeneca
- 研究主任:Ahmed Hadaoui, PharmD、AstraZeneca
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年2月17日
初级完成 (估计的)
2030年12月31日
研究完成 (估计的)
2030年12月31日
研究注册日期
首次提交
2018年5月15日
首先提交符合 QC 标准的
2018年5月29日
首次发布 (实际的)
2018年6月8日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- D1690R00044
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
合格的研究人员可以通过请求门户请求访问阿斯利康集团公司赞助的临床试验的匿名个人患者数据。 所有请求都将根据 AZ 披露承诺进行评估:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure。 是,表示 AZ 正在接受 IPD 请求,但这并不意味着所有请求都将共享。
IPD 共享时间框架
根据对 EFPIA 制药数据共享原则的承诺,阿斯利康将达到或超过数据可用性。
有关我们时间表的详细信息,请参阅我们在 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure 上的披露承诺。
IPD 共享访问标准
当请求获得批准后,阿斯利康将在批准的赞助工具中提供对去识别化的个体患者水平数据的访问。
在访问请求的信息之前,必须签署数据共享协议(数据访问者不可协商的合同)。
此外,所有用户都需要接受 SAS MSE 的条款和条件才能获得访问权限。
有关更多详细信息,请查看 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure 上的披露声明。
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.