- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03958760
Characteristics, Treatment, and Economic Burden of Patients With CVD,CKD or at High Cardiovascular Risk
Characteristics, Treatment, and Economic Burden of Disease of Chinese Diabetic/Non-diabetic Patients With/Without Established Cardiovascular Disease, Chronic Kidney Disease, or at High Cardiovascular Risk
Study Overview
Status
Detailed Description
The study aimed to investigate the clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk, including:
- estimate the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidaemia;
- describe the demographic and clinical characteristics of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- investigate the treatment patterns of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- examine economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease, CKD, or at high cardiovascular risk;
- explore the trends of clinical characteristics, treatment pattern, economic burden of inpatients over time (2008, 2013, and 2018 separately);
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Xin Sun, PhD
- Phone Number: +8618980606047
- Email: sunx79@hotmail.com
Study Locations
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Tian Jin
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Tian Jin, Tian Jin, China, 300000
- Tian Jin Healthcare Big Data Co. Ltd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients in the TianJin regional database from 2015 to 2018.
- patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic heart diseases (ICD-10 I20~I25);
- patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of cerebrovascular diseases (ICD-10 I60~I69);
- patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic peripheral artery disease (ICD-10 E10.501, E11.603, E14.501, E14.606, E14.503, I73.9, I99.03, I99.04);
- patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of heart failure (ICD-10 I50);
- inpatients with at least once 1 discharged diagnosis CKD (ICD-10 N18), or inpatients with the last estimated glomerular filtration rate (eGFR, calculated by CKD-EPI equation) <60 mL/min/1.73 m2 or prescription of dialysis, but not with the diagnosis of acute kidney injury (ICD-10 N17)
- Outpatients with at least 2 diagnosis of CKD or with two consecutive eGFR(calculated by CKD-EPI equation) <60 mL/min/1.73 m2 by 90 days or more.
- patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of hypertension (ICD-10 I10~I15);
- at least 1 discharged diagnosis or 2 outpatient diagnosis of hyperlipidaemia (ICD-10 E78.001-E78.003, E78.101, E78.203, E78.301-E78.304, E78.306, E78.401, E78.501, E78.902)
- patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of diabetes (ICD-10 E10-E14)
- In addition, we will randomly select a group of non-diabetic patients without any of the above diseases by matching on age and gender.
Exclusion Criteria:
- Patients with non-Chinese nationalities;
- Patients with abnormal bill (planning to define abnormal bill as the top 1-2.5% of total medical costs in three groups, respectively, but the final standard will be defined based on the real extracted data);
- Duplicated storage (records with same inpatient code).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Diabetic patients with CVD, CKD or at risk
The group A include all diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.
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Diabetic patients without CVD, CKD or at risk
The group B include all diabetic patients without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.
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Non-diabetic patients with CVD, CKD or at risk
The group C included all non-diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.
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Health controls
The group D included non-diabetic patients without established cardiovascular disease, chronic kidney disease, and not at high cardiovascular risk.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of diabetic/non-diabetic patients with disease or risk
Time Frame: 10 months after enrollment
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The number of diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among all patients with diabetes;
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10 months after enrollment
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The proportion of diabetic/non-diabetic patients with disease or risk
Time Frame: 10 months after enrollment
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The proportion of diabetic/non-diabetic patients with established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk among patients without diabetes
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10 months after enrollment
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The demographic characteristics of the last visit for all patients of the studied population
Time Frame: 10 months after enrollment
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10 months after enrollment
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The diagnosis of patients
Time Frame: 10 months after enrollment
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The number of patients with diagnosis at the last visit
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10 months after enrollment
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The proportion of death
Time Frame: 10 months after enrollment
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The proportion of death at the last visit; the proportion of death at admission of the last visit for inpatients in 2008, 2013 and 2018.
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10 months after enrollment
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Random blood glucose (mmol/L)
Time Frame: 12 months after enrollment
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The most recent value of random blood glucose (mmol/L) within the previous year for outpatients; the value of random blood glucose (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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HbA1C (%)
Time Frame: 12 months after enrollment
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The most recent value of HbA1C (%) within the previous year for outpatients; the value of HbA1C (%) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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Department of discharge for hospitalized patients
Time Frame: 12 months after enrollment
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Department of discharge of the last visit for hospitalized patients; and summarize the number of patients of different department of discharge in 2008, 2013, 2018.
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12 months after enrollment
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serum creatinine (μmol/L)
Time Frame: 12 months after enrollment
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The most recent value of serum creatinine (μmol/L) within the previous year for outpatients; the value of serum creatinine (μmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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eGFR (mL/min/1.73m2)
Time Frame: 12 months after enrollment
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The most recent value of eGFR (mL/min/1.73m2)
within the previous year for outpatients; the value of eGFR (mL/min/1.73m2)
at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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Microalbuminuria (MALB) (mg/24h)
Time Frame: 12 months after enrollment
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The most recent value of microalbuminuria (MALB, mg/24h) within the previous year for outpatients; the value of microalbuminuria (MALB, mg/24h) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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High density lipoprotein (HDL) (mmol/L)
Time Frame: 12 months after enrollment
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The lasted examination of high density lipoprotein (HDL) (mmol/L) within the last year for outpatients; the value of high density lipoprotein (HDL) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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Low density lipoprotein (LDL) (mmol/L)
Time Frame: 12 months after enrollment
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The lasted examination of low density lipoprotein (HDL) (mmol/L) within the last year for outpatients; the value of low density lipoprotein (HDL) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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Total cholesterol (TC) (mmol/L)
Time Frame: 12 months after enrollment
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The lasted examination of total cholesterol (TC) (mmol/L) within the last year for outpatients; the value of total cholesterol (TC) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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Triglyceride (TG) (mmol/L)
Time Frame: 12 months after enrollment
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The lasted examination of triglyceride (TG) (mmol/L) within the last year for outpatients; the value of triglyceride (TG) (mmol/L) at admission of the last visit for inpatients in 2008, 2013, 2018.
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12 months after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of patients with different treatment pattern
Time Frame: 10 months after enrollment
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We descirbe the treatment pattern based on treatment prescribed during the most recent visit for all inpatients, and based on at least 2 prescription within the previous year for outpatients |
10 months after enrollment
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The length of stay in the hospital
Time Frame: 12 months after enrollment
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describe the length of stay in the hospital of the last hospitalization, the length stay in the hospital for inpatients from 2008 to 2018.
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12 months after enrollment
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The economic burden
Time Frame: 12 months after enrollment
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hospitalization cost of the studied population for the last visit; total cost and hospitalization cost of the studied population from 2008 to 2018.
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12 months after enrollment
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Numbers of admissions
Time Frame: 12 months after enrollment
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The total number of admissions for inpatients from 2008 to 2018
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12 months after enrollment
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The proportion of re-hospitalization
Time Frame: 12 months after enrollment
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The last visiting and previous one within 30 days and 90 days
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12 months after enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xin Sun, PhD, The West China Hospital of Sichuan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Pathologic Processes
- Cardiovascular Diseases
- Urologic Diseases
- Disease Attributes
- Congenital Abnormalities
- Renal Insufficiency
- Stress, Psychological
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Cardiovascular Abnormalities
- Financial Stress
Other Study ID Numbers
- CREAT-DIABETES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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