China PEACE-Prospective 3-vessel Disease Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by China National Center for Cardiovascular Diseases
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01625312
First received: June 17, 2012
Last updated: February 5, 2014
Last verified: February 2014

June 17, 2012
February 5, 2014
December 2012
October 2013   (final data collection date for primary outcome measure)
Major adverse cardiac events (MACE) [ Time Frame: 1 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 NCT01625312 on ClinicalTrials.gov Archive Site
  • Coronary death or myocardial infarction (fatal or non-fatal MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Coronary revascularization procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Presumed ischemic stroke (i.e. not known to be hemorrhagic) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death from all cardiovascular causes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Re-admission [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Status of general health (SF-12) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of life (EQ-5D) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Symptoms status (SAQ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
China PEACE-Prospective 3-vessel Disease Study
The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Revascularization in 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 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.

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 25 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
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

Coronary Heart Disease
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
1500
November 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized 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:

  • Revascularization before the index admission
  • Previously enrolled in the PEACE study
Both
18 Years and older
No
Contact: Lixin Jiang, M.D., Ph.D. 86-10-8836-2967 lixin.jiang@fwoxford.org
Contact: Xi Li Xi, M.D., Ph.D. 86-10-8839-6082 ext 279 xi.li@fwoxford.org
China
 
NCT01625312
WSGY-201202025-5
Yes
China National Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases
Ministry of Health, China
Principal Investigator: Lixin Jiang, M.D., Ph.D. China National Center for Cardiovascular Diseases
Principal Investigator: Harlan M Krumholz, M.D., S.M. Yale University
China National Center for Cardiovascular Diseases
February 2014

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