Coronary Revascularization in Patients With Dialysis in China

Coronary Artery Disease Clinical Trial

— CRUISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953819
• Other study ID #: 2020-112-K71
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: June 2021
• Source: China-Japan Friendship Hospital
• Contact: Zhengqin Zhai
• Phone: +86 18612511571
• Email: zhengqin712[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Exclusion Criteria:

• Pregnancy or lactation.
• Can't be cooperative because of a mental illness or other reasons.
• Malignant tumor or severe hepatic disease.
• Life expectancy is less than 1 year.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dialysis
• Intervention
• Myocardial Ischemia

Intervention

Other:
• Revascularization
Percutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease
• Medical therapy
Optimal medical therapy for coronary artery disease

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all-cause death	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.	the duration of hospital stay, an expected average of 2 weeks
Primary	Incidence of all-cause death and non-fatal myocardial infarction	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.	12-month follow-up
Secondary	Incidence of all-cause death and non-fatal myocardial infarction	Definitions of all-cause death and non-fatal myocardial infarction as mentioned above.	within 30 days after discharge
Secondary	Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization.	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.	12-month follow-up
Secondary	Incidence of bleeding	Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding.	12-month follow-up