CRUISE: Coronary Revascularization in Patients With Dialysis in China

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04953819

Collaborator

(none)

1,000

Enrollment

Location

33.9

Anticipated Duration (Months)

29.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. It remains unclear that what their treatment status is and whether this group of patients can benefit from revascularization in China. The investigators plan to recruit around 30 hospitals from 7 regions as study centers, which represent different levels of economic development in Mainland China. The detailed information includes demographics, medical history, coronary angiogram, in-hospital treatment and procedures, short-term and long-term outcomes. The aim of the study is to provide the real world knowledge about current status of coronary revascularization and prognosis in patients with CAD and dialysis.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Dialysis Intervention	Other: Revascularization Other: Medical therapy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Coronary RevascUlarization in Patients With End-stage Renal dIsease on dialysiS in China: a Nationwide and multicEnter Cohort Study.

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Revascularization group This group includes patients with dialysis who have received revascularization by percutaneous coronary intervention or coronary artery bypass grafting for coronary artery disease.	Other: Revascularization Percutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease Other Names: Catheterization or coronary bypass grafting
Medical treatment group This group includes patients who have received medical therapy for coronary artery disease, not percutaneous coronary intervention or coronary artery bypass grafting.	Other: Medical therapy Optimal medical therapy for coronary artery disease

Arm

Intervention/Treatment

Revascularization group

This group includes patients with dialysis who have received revascularization by percutaneous coronary intervention or coronary artery bypass grafting for coronary artery disease.

Other: Revascularization

Percutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease

Other Names:

Catheterization or coronary bypass grafting

Medical treatment group

This group includes patients who have received medical therapy for coronary artery disease, not percutaneous coronary intervention or coronary artery bypass grafting.

Other: Medical therapy

Optimal medical therapy for coronary artery disease

Outcome Measures

Primary Outcome Measures

Incidence of all-cause death [the duration of hospital stay, an expected average of 2 weeks]
All-cause deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 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.
Incidence of all-cause death and non-fatal myocardial infarction [12-month follow-up]
Non-fatal myocardial infarction is defined as elevated cardiac enzymes (troponin or myocardial band fraction of creatine kinase) above the upper reference limit with ischemic symptoms or electrocardiography findings indicative of ischemia that is not related to the index procedure.

Secondary Outcome Measures

Incidence of all-cause death and non-fatal myocardial infarction [within 30 days after discharge]
Definitions of all-cause death and non-fatal myocardial infarction as mentioned above.
Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization. [12-month follow-up]
Definitions of all-cause death and non-fatal myocardial infarction as mentioned above. Non-fatal stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause. Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG. Cardiovascular rehospitalization is rehospitalization due to MI, angina, heart failure, stroke, arrhythmia or conduction disturbance, sudden cardiac arrest and other cardiovascular problem.
Incidence of bleeding [12-month follow-up]
Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18 or above and 85 or below.
Receives peritoneal dialysis or hemodialysis more than 1-time weekly and for more than 3 months.
Diagnosed with coronary artery disease, including STEMI, NST-ACD, stable coronary artery disease.