PEACE Prospective Study of Patients With Three-vessel Disease (PEACE3VD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by China National Center for Cardiovascular Diseases
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01617785
First received: June 8, 2012
Last updated: August 13, 2013
Last verified: June 2012

June 8, 2012
August 13, 2013
December 2011
December 2013   (final data collection date for primary outcome measure)
Major adverse cardiac events (MACE) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.
Same as current
Complete list of historical versions of study NCT01617785 on ClinicalTrials.gov Archive Site
  • Coronary death or myocardial infarction (fatal or non-fatal MI) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Coronary revascularization procedure [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Presumed ischemic stroke (i.e. not known to be hemorrhagic) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Death from all cardiovascular causes [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Re-admission [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Status of general health (SF-12) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Quality of life (EQ-5D) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PEACE Prospective Study of Patients With Three-vessel Disease
Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Three-vessel Coronary Heart Disease

Coronary heart disease (CHD) pose a serious health threaten to population. Optimal revascularization strategy in multiple vessel coronary artery disease patients remains a subject of debate between interventional cardiologists and surgeons. Knowledge about the real-life revascularization pattern and outcomes in China is limited. By consecutively recruiting three vessel coronary heart disease patients in 23 geographically representative highest-rank hospitals, this study will examine revascularization strategy, and various real-life factors, that may affect patients lone-term recovery. Practical guidelines, appropriateness criteria and quality evaluative system for revascularization strategy will be established based on the findings, to improve patients outcomes in future finally.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

elective patients for coronary angiogram.

  • Coronary Artery Disease
  • Therapeutics
  • Outcome Assessment
Not Provided
  • CABG group
    Three-vessel disease patients undergoing CABG at index hospitalization
  • PCI group
    Three-vessel disease patients undergoing PCI at index hospitalization
  • OMT group
    Three-vessel disease patients undergoing no revascularization at index hospitalization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4500
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized elective patients with diagnosis of three-vessel disease, or left main disease with significant lesion (over 50%), using selective coronary angiography at index hospitalization

Exclusion Criteria:

  • Emergent patients, 1-2 vessel disease, Previous CABG or PCI, Combined with other diseases needed cardiac surgery
Both
18 Years and older
No
Contact: Zhe Zheng, M.D. zhengzhe@fuwai.com
China
 
NCT01617785
fuwai201112
Yes
China National Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases
Ministry of Science and Technology of the People´s Republic of China
Principal Investigator: Shengshou Hu, M.D. National Center for Cardiovascular Diseases
Principal Investigator: Harlan M Krumholz, M.D., S.M. Yale University
China National Center for Cardiovascular Diseases
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP