Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry
- Conditions
- End Stage Renal DiseaseDialysisCoronary Artery Disease
- Registration Number
- NCT05841082
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1249
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause death 12-month follow-up 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.
- Secondary Outcome Measures
Name Time Method Cardiovascular death From the hospital admission to 12-month follow-up Cardiovascular death is defined as death due to acute myocardial infarction, heart failure, sudden cardiac death, stroke, cardiovascular procedure, or cardiovascular hemorrhage.
Non-fatal myocardial infarction From the hospital admission to 12-month follow-up Non-fatal myocardial infarction is confirmed in patients with ischemic symptoms, elevated serum cardiac biomarkers and/or distinctive ECG changes.
Clinically relevant nonmajor bleeding From the hospital admission to 12-month follow-up A bleeding event meeting Bleeding Academic Research Consortium criteria type 2.
Major adverse cardiovascular events From the hospital admission to 12-month follow-up A composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
Major bleeding From the hospital admission to 12-month follow-up A bleeding event meeting Bleeding Academic Research Consortium criteria type 3, or 5.
Major or clinically relevant nonmajor bleeding From the hospital admission to 12-month follow-up A bleeding event meeting Bleeding Academic Research Consortium criteria type 2, 3, or 5.
Non-fatal myocardial stroke From the hospital admission to 12-month follow-up 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.
Follow-up major adverse cardiovascular and clinical events From the hospital admission, and up to 10 years We will follow up the patients by telephone and outpatient service to know the all-cause mortality (cardiovascular and non-cardiovascular) and cardiovascular events.
Trial Locations
- Locations (1)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China