Coronary Revascularization in Patients With Dialysis in China

NCT04953819 | Unknown

• 1 other identifier: 2020-112-K71
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Dialysis; Intervention

Keywords

dialysis; coronary artery disease; revascularization; optimal medical therapy; prognosis

Outcome Measures

Primary Outcomes (2)

• Incidence of all-cause death

  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

  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 Outcomes (3)

• Incidence of all-cause death and non-fatal myocardial infarction

  within 30 days after discharge

• Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization.

  12-month follow-up

• Incidence of bleeding

  12-month follow-up

Study Arms (2)

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

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

Interventions

Revascularization OTHER

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

Also known as: Catheterization or coronary bypass grafting

Revascularization group

Medical therapy OTHER

Optimal medical therapy for coronary artery disease

Medical treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Catheterization; Nutrition Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Jingang Zheng

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengqin Zhai

CONTACT

+86 18612511571; zhengqin712@outlook.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Cardiology, China-Japan Friendship Hospital

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 8, 2021
• Study Start: November 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: July 8, 2021

Record last verified: 2021-06

Locations

CN (1)