Coronary Revascularization in Patients With Dialysis in China (CRUISE)

June 28, 2021 updated by: Jingang Zheng, China-Japan Friendship Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population of this study will be selected from around 30 different hospitals in 7 different areas in China.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all-cause death
Time Frame: the duration of hospital stay, an expected average of 2 weeks

All-cause deaths includes cardiac death, vascular death and non-cardiovascular death.

  1. 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.
  2. Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases.
  3. 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
Incidence of all-cause death and non-fatal myocardial infarction
Time Frame: 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.
12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all-cause death and non-fatal myocardial infarction
Time Frame: within 30 days after discharge
Definitions of all-cause death and non-fatal myocardial infarction as mentioned above.
within 30 days after discharge
Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization.
Time Frame: 12-month follow-up
  1. Definitions of all-cause death and non-fatal myocardial infarction as mentioned above.
  2. 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.
  3. Repeat revascularization is any unplanned repeat revascularization of either a target vessel or non-target vessel or CABG.
  4. 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
Incidence of bleeding
Time Frame: 12-month follow-up
Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding.
12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Investigators

  • Principal Investigator: Jingang Zheng, China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-112-K71

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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