PEACE Prospective Study of Patients With Three-vessel Disease

NCT01617785 | Unknown DMC

• 1 other identifier: fuwai201112
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Therapeutics; Outcome Assessment

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACE)

  Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.

  one year

Secondary Outcomes (8)

• Coronary death or myocardial infarction (fatal or non-fatal MI)

  one year

• Coronary revascularization procedure

  one year

• Presumed ischemic stroke (i.e. not known to be hemorrhagic)

  one year

• Death from all cardiovascular causes

  one year

• Re-admission

  one year

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elective patients for coronary angiogram.

You may qualify if:

• 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

You may not qualify if:

• Emergent patients, 1-2 vessel disease, Previous CABG or PCI, Combined with other diseases needed cardiac surgery

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shengshou Hu, M.D.

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Harlan M Krumholz, M.D., S.M.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Zheng, M.D.

CONTACT

zhengzhe@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: August 14, 2013

Record last verified: 2012-06

Locations

CN (1)