China PEACE-Prospective 3-vessel Disease Study

Coronary Heart Disease Clinical Trial

Official title:

The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Revascularization in Patients With Three-vessel Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625312
• Other study ID #: WSGY-201202025-5
• Status: Completed
• Phase: N/A
• First received: June 17, 2012
• Last updated: May 3, 2015
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2339
• Est. completion date: December 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Ministry of Health, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACE)	Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.	1 year	Yes
Secondary	Coronary death or myocardial infarction (fatal or non-fatal MI)		1 year	Yes
Secondary	Coronary revascularization procedure		1 year	Yes
Secondary	Presumed ischemic stroke (i.e. not known to be hemorrhagic)		1 year	Yes
Secondary	Death from all cardiovascular causes		1 year	Yes
Secondary	Re-admission		1 year	Yes
Secondary	Status of general health (SF-12)		1 year	Yes
Secondary	Quality of life (EQ-5D)		1 year	Yes
Secondary	Symptoms status (SAQ)		1 year	Yes