PEACE Prospective Study of Patients With Three-vessel Disease (PEACE3VD)
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|ClinicalTrials.gov Identifier: NCT01617785|
Recruitment Status : Unknown
Verified June 2012 by China National Center for Cardiovascular Diseases.
Recruitment status was: Recruiting
First Posted : June 12, 2012
Last Update Posted : August 14, 2013
|Condition or disease|
|Coronary Artery Disease Therapeutics Outcome Assessment|
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 23 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|
|Estimated Enrollment :||4500 participants|
|Official Title:||Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Three-vessel Coronary Heart Disease|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated 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: one 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: one year ]
- Coronary revascularization procedure [ Time Frame: one year ]
- Presumed ischemic stroke (i.e. not known to be hemorrhagic) [ Time Frame: one year ]
- Death from all cardiovascular causes [ Time Frame: one year ]
- Re-admission [ Time Frame: one year ]
- Status of general health (SF-12) [ Time Frame: one year ]
- Quality of life (EQ-5D) [ Time Frame: one year ]
- Cost-effectiveness [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617785
|Contact: Zhe Zheng, M.D.||email@example.com|
|National Center for Cardiovascular Diseases||Recruiting|
|Beijing, Beijing, China, 100037|
|Contact: Zhe Zheng, M.D. firstname.lastname@example.org|
|Principal Investigator:||Shengshou Hu, M.D.||National Center for Cardiovascular Diseases|
|Principal Investigator:||Harlan M Krumholz, M.D., S.M.||Yale University|