China PEACE-Prospective PCI Study

NCT ID: NCT01624922

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients undergoing a percutaneous coronary intervention (PCI) with stents implantation for coronary lesions.

Exclusion Criteria

* Previously enrolled in the PEACE study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lixin Jiang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China National Center for Cardiovascular Diseases

Harlan M Krumholz, M.D., S.M.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32131687 (View on PubMed)

Other Identifiers

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WSGY-201202025-4

Identifier Type: -

Identifier Source: org_study_id