NCT01625312

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 25 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,339

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 5, 2015

Status Verified

September 1, 2014

Enrollment Period

10 months

First QC Date

June 17, 2012

Last Update Submit

May 3, 2015

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events (MACE)

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

    1 year

Secondary Outcomes (8)

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

    1 year

  • Coronary revascularization procedure

    1 year

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

    1 year

  • Death from all cardiovascular causes

    1 year

  • Re-admission

    1 year

  • +3 more secondary outcomes

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In 25 tertiary hospitals with capability of Percutaneous Coronary Intervention and CABG in China, 1500 hospitalized patients diagnosed as three-vessel coronary heart disease following elective coronary angiograghy will be enrolled consecutively.

You may qualify if:

  • Hospitalized 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:

  • Revascularization before the index admission
  • Previously enrolled in the PEACE study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

  • Rao C, Bongiovanni T, Li X, Gao H, Zhang H, Li J, Zhao Y, Yuan X, Hua K, Hu S, Krumholz HM, Jiang L, Zheng Z; China PEACE Collaborative Group. The China Patient-Centred Evaluative Assessment of Cardiac Events (China PEACE)-Prospective Study of 3-Vessel Disease: rationale and design. BMJ Open. 2016 Feb 15;6(2):e009743. doi: 10.1136/bmjopen-2015-009743.

    PMID: 26880670DERIVED

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.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Lixin Jiang, M.D., Ph.D.

    China National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

  • Harlan M Krumholz, M.D., S.M.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 21, 2012

Study Start

December 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2014

Last Updated

May 5, 2015

Record last verified: 2014-09

Locations

CN(1)