- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04407936
Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention
September 8, 2021 updated by: Jiyan Chen, Guangdong Provincial People's Hospital
As a single center, retrospective observation study in Guangdong Institute of Cardiovascular Diseases, this study included the main study population of patients who underwent coronary angiography and / or coronary intervention from January 2007 to Decemeber 2018.
The hospitalization information was collected in the form of direct derivation of the case, and cardiac and renal adverse events were collected through outpatient recorder system.
All-cause death information was obtained from the Public Security and matched to the electronic Clinical Management System of the Guangdong Provincial People's Hospital records.
Study Overview
Status
Completed
Detailed Description
This is a single center, retrospective observation study collecting data on 88938 coronary angiography and / or coronary intervention patients from January 2007 to Decemeber 2018.
Data regarding demographic information, admission diagnoses and history of present illness, biomarkers and details on preventive hydration and medications will be collected.
The primary endpoint of this study is All-cause mortality, and secondary endpoints are Adverse Cardiovascular and Kidney Events.
Study Type
Observational
Enrollment (Actual)
88938
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The investigators reviewed all consecutive patients who were undergoing coronary angiography
Description
Inclusion Criteria:
1. Patients referred to CAG or PCI;
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
coronary angiography
The investigators recruit all consecutive patients who were undergoing coronary angiography or percutaneous coronary intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: From hospital admission to 13 years follow-up
|
Admission Patients Died for all-cause mortality within 13 years.
|
From hospital admission to 13 years follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contrast-Induced Acute Kidney Injury (CI-AKI 0.3)
Time Frame: 48 hours
|
defined as a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure
|
48 hours
|
Incidence of major adverse cardiovascular events
Time Frame: 3-12months
|
all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.
|
3-12months
|
Follow-up major adverse cardiovascular and clinical events
Time Frame: 3-12months
|
We will follow up the patients by telephone and outpatient service to know the one year all-cause mortality (cardiovascular and noncardiovascular) and cardiovascular events.
|
3-12months
|
Cystatin C based CI-AKI (CI-AKI cyc)
Time Frame: 24-48 hours
|
Cystatin C based CI-AKI, defined as a ≥10% absolute increase in serum cystatin C during the first 24 hours after the procedure and and a ≥ 0.3 mg/dL absolute increase in serum creatinine from baseline during the first 48 hours after the procedure.mg/dL
absolute increase in serum creatinine from baseline during the first 48 hours after the procedure
|
24-48 hours
|
The change of eGFR, calculate based on CrCl and serum cystatin C
Time Frame: 48-72 hours
|
The eGFR creatinine-cystatin C was calculated by the 2012 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation: 135 *min(Scr/κ, 1)α * max(Scr/κ, 1)-0.601
* min(Scys/0.8,
1)-0.375 * max (Scys/0.8,
1)-0.711
* 0.995Age [* 0.969 if female] [* 1.08 if black], where Scr is serum creatinine, Scys is serum cystatin C, κ is 0.7 for females and 0.9 for males, α is -0.248 for females and -0.207 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
|
48-72 hours
|
Contrast-induced Persistent kidney injury (CI-PKI)
Time Frame: 3 months
|
Serum creatinine was measured by endpoint colorimetry or enzymatic assays.
CI-PKI was defined as residual impairment of renal function indicated by a ≥ 25% reduction in creatinine clearance at 3 months in comparison with baseline.
comparison with baseline
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Shiqun Chen, MS, Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
- Study Director: Liu Yong, MD,PhD, Guangdong Cardiovascular Institute,Guangdong Provincial People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chen S, Huang Z, Liang Y, Zhao X, Aobuliksimu X, Wang B, He Y, Kang Y, Huang H, Li Q, Yao Y, Lu X, Qian X, Xie X, Liu J, Liu Y. Five-year mortality of heart failure with preserved, mildly reduced, and reduced ejection fraction in a 4880 Chinese cohort. ESC Heart Fail. 2022 Aug;9(4):2336-2347. doi: 10.1002/ehf2.13921. Epub 2022 Apr 18.
- Lai W, Zhao X, Yu S, Mai Z, Zhou Y, Huang Z, Li Q, Huang H, Li H, Wei H, Guo D, Xie Y, Li S, Lu H, Liu J, Chen S, Liu Y. Chronic Kidney Disease Increases Risk of Incident HFrEF Following Percutaneous Coronary Intervention. Front Cardiovasc Med. 2022 Apr 1;9:856602. doi: 10.3389/fcvm.2022.856602. eCollection 2022.
- Huang H, Liu J, Bao K, Huang X, Huang D, Wei H, Remutula N, Tuersun T, Lai W, Li Q, Wang B, He Y, Yang H, Chen S, Chen J, Chen K, Tan N, Wang X, Chen L, Liu Y. Prevalence and Mortality of Moderate or Severe Mitral Regurgitation Among Patients Undergoing Percutaneous Coronary Intervention With or Without Heart Failure: Results From CIN Study With 28,358 Patients. Front Cardiovasc Med. 2022 Mar 3;9:796447. doi: 10.3389/fcvm.2022.796447. eCollection 2022.
- Chen L, Huang Z, Zhao X, Liang J, Lu X, He Y, Kang Y, Xie Y, Liu J, Liu Y, Yang J, Yu W, Deng W, Pan Y, Lu J, Yang Y, Xie X, Qian X, Xu Q, Chen L, Chen K, Chen S. Predictors and Mortality for Worsening Left Ventricular Ejection Fraction in Patients With HFpEF. Front Cardiovasc Med. 2022 Feb 24;9:820178. doi: 10.3389/fcvm.2022.820178. eCollection 2022.
- Liu J, Huang Z, Huang H, He Y, Yu Y, Chen G, Liu L, Wang B, Li Q, Lai W, Xu D, Lu J, Yang Y, Chen L, Chen K, Tan N, Chen J, Chen S, Liu Y. Malnutrition in patients with coronary artery disease: Prevalence and mortality in a 46,485 Chinese cohort study. Nutr Metab Cardiovasc Dis. 2022 May;32(5):1186-1194. doi: 10.1016/j.numecd.2021.12.023. Epub 2022 Jan 6.
- Chen S, Huang Z, Chen L, Zhao X, Kang Y, Lai W, Lu X, Zhou Y, He Y, Huang H, Li Q, Liu J, Liang Y, Dong S, Tan N, Liu Y, Chen J. Does Diabetes Mellitus Increase the Short- and Long-Term Mortality in Patients With Critical Acute Myocardial Infarction? Results From American MIMIC-III and Chinese CIN Cohorts. Front Endocrinol (Lausanne). 2021 Dec 14;12:797049. doi: 10.3389/fendo.2021.797049. eCollection 2021.
- Huang Z, Yang Y, Lu J, Liang J, He Y, Yu Y, Huang H, Li Q, Wang B, Li S, Yan Z, Xu D, Liu Y, Chen K, Huang Z, Ni J, Liu J, Chen L, Chen S. Association of Lipoprotein(a)-Associated Mortality and the Estimated Glomerular Filtration Rate Level in Patients Undergoing Coronary Angiography: A 51,500 Cohort Study. Front Cardiovasc Med. 2021 Nov 17;8:747120. doi: 10.3389/fcvm.2021.747120. eCollection 2021.
- Wang B, Guo Z, Liu J, Li H, Mai Z, Lin F, Ying M, Yu Y, Chen S, Li Q, Huang H, Wei W, Yang Y, Dong S, Zhou Y, Chen J, Tan N, Liu Y. Mild Malnutrition Contributes the Greatest to the Poor Prognosis in Coronary Artery Disease With Well-Controlled Low-Density Lipoprotein Cholesterol Levels: A 4,863 Chinese Cohort Study. Front Nutr. 2021 Sep 29;8:725537. doi: 10.3389/fnut.2021.725537. eCollection 2021.
- Mai Z, Huang Z, Lai W, Li H, Wang B, Huang S, Shi Y, Yu S, Hu Q, Liu J, Zhang L, Liu Y, Chen J, Liang Y, Zhong S, Chen S. Association of Malnutrition, Left Ventricular Ejection Fraction Category, and Mortality in Patients Undergoing Coronary Angiography: A Cohort With 45,826 Patients. Front Nutr. 2021 Sep 16;8:740746. doi: 10.3389/fnut.2021.740746. eCollection 2021. Erratum In: Front Nutr. 2022 Apr 04;9:890490.
- Liu J, Li Q, Lai D, Chen G, Wang B, Liu L, Huang H, Lun Z, Ying M, Chen G, Huang Z, Xu D, Meng L, Yan X, Qiu W, Tan N, Chen J, Liu Y, Chen S. Trends in incidence and long-term prognosis of acute kidney injury following coronary angiography in Chinese cohort with 11,943 patients from 2013 to 2017: an observational study. BMC Nephrol. 2021 Jun 25;22(1):235. doi: 10.1186/s12882-021-02427-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2007
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
March 10, 2020
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
May 29, 2020
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Urologic Diseases
- Disease
- Renal Insufficiency
- Insulin Resistance
- Hyperinsulinism
- Coronary Disease
- Heart Failure
- Coronary Artery Disease
- Syndrome
- Kidney Diseases
- Metabolic Syndrome
- Cardio-Renal Syndrome
Other Study ID Numbers
- GDREC2019555H
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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