Clinical trial NCT01624922: China PEACE-Prospective PCI Study
Official title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, China
First posted: 2012-06-21
Enrollment: 5185
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: In 30 tertiary hospitals with capability of Percutaneous Coronary Intervention in China, 3000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.

Brief summary: Coronary heart disease (CHD) pose a serious health threaten to population. PCI, as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life PCI use in China is limited. By consecutively recruiting PCI patients in 30 geographically representative highest-rank hospitals, this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI 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. In addition, little information is available about the magnitude and quality of PCI, which has developed rapidly during the past several decades. 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 undergoing PCI after admission consecutively in 30 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 patients recovery after PCI, 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 patients undergoing a percutaneous coronary intervention (PCI) with stents implantation for coronary lesions.

Exclusion Criteria:

* Previously enrolled in the PEACE study

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 1 year
Secondary outcomes:
measure: Symptoms status (SAQ)
timeFrame: 1 year
measure: Quality of life (EQ-5D)
timeFrame: 1 year
measure: Depression (PHQ-8)
timeFrame: 1 year
measure: Stress (PSS-4)
timeFrame: 1 year
measure: Cardiac death
timeFrame: 1 year
measure: Fatal or non-fatal AMI
timeFrame: 1 year
measure: Coronary revascularization procedure
timeFrame: 1 year
measure: Ischemic stroke
timeFrame: 1 year
measure: Re-admission
timeFrame: 1 year
measure: Adherence to medications for secondary prevention
timeFrame: 1 year
measure: Control of risk factors
timeFrame: 1 year
Other outcomes:
measure: Cognitive function (MMSE)
timeFrame: 1 year
measure: Sexual activity/function
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Lixin Jiang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Harlan M Krumholz, M.D., S.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng X, Dreyer RP, Curtis JP, Liu S, Xu X, Bai X, Li X, Zhang H, Wang S, Masoudi FA, Spertus JA, Li J, Krumholz HM; China PEACE Collaborative Group. Sex Differences in 1-Year Health Status Following Percutaneous Coronary Intervention in Patients Without Acute Myocardial Infarction: Results From the China PEACE Prospective Study. J Am Heart Assoc. 2020 Mar 17;9(6):e014421. doi: 10.1161/JAHA.119.014421. Epub 2020 Mar 5.