Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry

Study Overview
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Brief Summary
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Coronary artery disease (CAD) is the leading cause of death in end-stage renal disease (ESRD) patients requiring dialysis. There are limited data on clinical characteristics, treatment strategies and outcomes in this special patient population in China. As a nationwide, observational, multicenter cohort study, this study consecutively included ESRD patients on dialysis with significant CAD at 30 tertiary care centers in 12 provinces in China from January 2015 to June 2021. Patient data collected included demographics, comorbidities, cardiac history, cardiac function, location and severity of CAD, procedural information, medications, and clinical events.

Official Title
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Coronary RevascUlarIzation in Patients With End-StagE Renal Disease on Dialysis in China-Retrospective Registry

Conditions
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Coronary Artery Disease, End Stage Renal Disease, Dialysis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram Receive peritoneal dialysis or hemodialysis for more than 3 months Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAD<br>The investigators recruited all consecutive end-stage renal disease patients requiring dialysis who had significant coronary artery disease, defined as 50% or greater stenosis in any of three main coronary arteries or left main coronary artery on visual assessment of the coronary angiogram | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | All-cause deaths include cardiovascular death and non-cardiovascular death. Cardiovascular death is defined as death due to acute myocardial infarction, heart failure, sudden cardiac death, stroke, cardiovascular procedure, or cardiovascular hemorrhage. Non-cardiovascular death: any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma. | 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | A composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. | From the hospital admission to 12-month follow-up | 
| Major or clinically relevant nonmajor bleeding | A bleeding event meeting Bleeding Academic Research Consortium criteria type 2, 3, or 5. | From the hospital admission to 12-month follow-up | 
| Cardiovascular death | Cardiovascular death is defined as death due to acute myocardial infarction, heart failure, sudden cardiac death, stroke, cardiovascular procedure, or cardiovascular hemorrhage. | From the hospital admission to 12-month follow-up | 
| Non-fatal myocardial infarction | Non-fatal myocardial infarction is confirmed in patients with ischemic symptoms, elevated serum cardiac biomarkers and/or distinctive ECG changes. | From the hospital admission to 12-month follow-up | 
| Non-fatal myocardial stroke | Non-fatal myocardial stroke is confirmed as a new neurological deficit attributed to a vascular cause in the central nervous system with imaging evidence by computed tomography or magnetic resonance imaging. | From the hospital admission to 12-month follow-up | 
| Major bleeding | A bleeding event meeting Bleeding Academic Research Consortium criteria type 3, or 5. | From the hospital admission to 12-month follow-up | 
| Clinically relevant nonmajor bleeding | A bleeding event meeting Bleeding Academic Research Consortium criteria type 2. | From the hospital admission to 12-month follow-up | 
| Follow-up major adverse cardiovascular and clinical events | We will follow up the patients by telephone and outpatient service to know the all-cause mortality (cardiovascular and non-cardiovascular) and cardiovascular events. | From the hospital admission, and up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, end-stage renal disease, cardiac catheterizations, percutaneous coronary intervention, coronary artery bypass grafting, prognosis, metabolic Syndrome, revascularization, optimal medical therapy