Clinical trial NCT01617785: PEACE Prospective Study of Patients With Three-vessel Disease
Official title: Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Prospective Study of Patients With Three-vessel Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Therapeutics
Outcome Assessment
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2012-06-12
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elective patients for coronary angiogram.

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.

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 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

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: one year
Secondary outcomes:
measure: Coronary death or myocardial infarction (fatal or non-fatal MI)
timeFrame: one year
measure: Coronary revascularization procedure
timeFrame: one year
measure: Presumed ischemic stroke (i.e. not known to be hemorrhagic)
timeFrame: one year
measure: Death from all cardiovascular causes
timeFrame: one year
measure: Re-admission
timeFrame: one year
measure: Status of general health (SF-12)
timeFrame: one year
measure: Quality of life (EQ-5D)
timeFrame: one year
measure: Cost-effectiveness
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: National Center for Cardiovascular Diseases
name: Shengshou Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Harlan M Krumholz, M.D., S.M.
role: PRINCIPAL_INVESTIGATOR
References: