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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
  Purpose

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.


Condition
Coronary Artery Disease
Therapeutics
Outcome Assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Three-vessel Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4500
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

elective patients for coronary angiogram.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617785

Contacts
Contact: Zhe Zheng, M.D. zhengzhe@fuwai.com

Locations
China, Beijing
National Center for Cardiovascular Diseases Recruiting
Beijing, Beijing, China, 100037
Contact: Zhe Zheng, M.D.       zhengzhe@fuwai.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Ministry of Science and Technology of the People´s Republic of China
Investigators
Principal Investigator: Shengshou Hu, M.D. National Center for Cardiovascular Diseases
Principal Investigator: Harlan M Krumholz, M.D., S.M. Yale University
  More Information

No publications provided

Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01617785     History of Changes
Other Study ID Numbers: fuwai201112
Study First Received: June 8, 2012
Last Updated: August 13, 2013
Health Authority: China: Ministry of Science and Technology

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014