China PEACE-Prospective 3-vessel Disease Study
Coronary Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Revascularization in Patients With Three-vessel Coronary Heart Disease|
- Major adverse cardiac events (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Coronary revascularization procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Presumed ischemic stroke (i.e. not known to be hemorrhagic) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Death from all cardiovascular causes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Re-admission [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Status of general health (SF-12) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Quality of life (EQ-5D) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Symptoms status (SAQ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||December 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|