China PEACE-Prospective 3-vessel Disease Study
|ClinicalTrials.gov Identifier: NCT01625312|
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : May 5, 2015
|Condition or disease|
|Coronary Heart Disease|
Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.
This study will enroll patients with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%) consecutively in 25 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect multiple vessel coronary heart disease patients recovery after PCI/CABG/medications, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.
|Study Type :||Observational|
|Actual Enrollment :||2339 participants|
|Official Title:||The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Revascularization in Patients With Three-vessel Coronary Heart Disease|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||December 2014|
Three-vessel disease patients undergoing CABG at index hospitalization
Three-vessel disease patients undergoing PCI at index hospitalization.
Three-vessel disease patients undergoing no revascularization at index hospitalization
- Major adverse cardiac events (MACE) [ Time Frame: 1 year ]Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.
- Coronary death or myocardial infarction (fatal or non-fatal MI) [ Time Frame: 1 year ]
- Coronary revascularization procedure [ Time Frame: 1 year ]
- Presumed ischemic stroke (i.e. not known to be hemorrhagic) [ Time Frame: 1 year ]
- Death from all cardiovascular causes [ Time Frame: 1 year ]
- Re-admission [ Time Frame: 1 year ]
- Status of general health (SF-12) [ Time Frame: 1 year ]
- Quality of life (EQ-5D) [ Time Frame: 1 year ]
- Symptoms status (SAQ) [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
A venous blood sample of 20mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage for future genetic studies;
A urine samples of 40mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625312
|Beijing, Beijing, China, 100037|
|Principal Investigator:||Lixin Jiang, M.D., Ph.D.||China National Center for Cardiovascular Diseases|
|Principal Investigator:||Harlan M Krumholz, M.D., S.M.||Yale University|