Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry (CRUISE-R)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; End Stage Renal Disease; Dialysis

• Study Type: Observational
• Enrollment (Actual): 1249

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population of this study will be selected from January 2015 to June 2021 among 30 tertiary medical centers across 12 provinces in China

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CAD; 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?

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Wuhan University; Peking University People's Hospital; West China Hospital; Tongji Hospital; Shengjing Hospital; Xuanwu Hospital, Beijing; Peking University Shougang Hospital; Beijing Chao Yang Hospital; Guangdong Provincial People's Hospital; People's Hospital of Xinjiang Uygur Autonomous Region; Tianjin Medical University General Hospital; Zhejiang University; Shaoxing People's Hospital; First Affiliated Hospital of Xinjiang Medical University; Ningbo No. 1 Hospital; Fifth Affiliated Hospital of Xinjiang Medical University; People's Hospital of Guangxi; Civil Aviation General Hospital; Fuwai Yunnan Cardiovascular Hospital; The Third People's Hospital of Chengdu; Emergency General Hospital; Henan Provincial Chest Hospital; Dongguan Tungwah Hospital; Aerospace Center Hospital; Cangzhou Central Hospital of Tianjin Medical University; First Central Hospital of Tianjin; Second Hospital of Tianjin Medical University; the First Affiliated Hospital, Harbin Medical University; Tianjin Union Medicine Center
• Investigators: Principal Investigator: Jingang Zheng, MD, PhD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 30, 2021
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: April 22, 2023
• First Submitted That Met QC Criteria: April 23, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; prognosis; coronary artery disease; end-stage renal disease; coronary artery bypass grafting; revascularization; optimal medical therapy; cardiac catheterizations; metabolic Syndrome
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: CRUISE-2020-12-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No