Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry

Coronary Artery Disease Clinical Trial

— CRUISE-R  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05841082
• Other study ID #: CRUISE-2020-12-28
• Status: Active, not recruiting
• Start date: January 1, 2015
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1249
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dialysis
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Myocardial Ischemia

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (30)

Lead Sponsor

Collaborator

China-Japan Friendship Hospital

Aerospace Center Hospital, Beijing Chao Yang Hospital, Cangzhou Central Hospital of Tianjin Medical University, Civil Aviation General Hospital, Dongguan Tungwah Hospital, Emergency General Hospital, Fifth Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Xinjiang Medical University, First Central Hospital of Tianjin, Fuwai Yunnan Cardiovascular Hospital, Guangdong Provincial People's Hospital, Henan Provincial Chest Hospital, Ningbo No. 1 Hospital, Peking University People's Hospital, Peking University Shougang Hospital, People's Hospital of Guangxi, People's Hospital of Xinjiang Uygur Autonomous Region, Second Hospital of Tianjin Medical University, Shaoxing People's Hospital, Shengjing Hospital, the First Affiliated Hospital, Harbin Medical University, The Third People's Hospital of Chengdu, Tianjin Medical University General Hospital, Tianjin Union Medicine Center, Tongji Hospital, West China Hospital, Wuhan University, Xuanwu Hospital, Beijing, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Major bleeding	A bleeding event meeting Bleeding Academic Research Consortium criteria type 3, or 5.	From the hospital admission to 12-month follow-up
Secondary	Clinically relevant nonmajor bleeding	A bleeding event meeting Bleeding Academic Research Consortium criteria type 2.	From the hospital admission to 12-month follow-up
Secondary	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