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China PEACE-Prospective PCI Study

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ClinicalTrials.gov Identifier: NCT01624922
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : August 31, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Coronary Heart Disease

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.

Study Design

Study Type : Observational
Actual Enrollment : 5185 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Percutaneous Coronary Intervention
Study Start Date : December 2012
Primary Completion Date : August 2013
Study Completion Date : July 2015
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Major adverse cardiovascular events (MACE) [ Time Frame: 1 year ]
    Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke.

Secondary Outcome Measures :
  1. Symptoms status (SAQ) [ Time Frame: 1 year ]
  2. Quality of life (EQ-5D) [ Time Frame: 1 year ]
  3. Depression (PHQ-8) [ Time Frame: 1 year ]
  4. Stress (PSS-4) [ Time Frame: 1 year ]
  5. Cardiac death [ Time Frame: 1 year ]
  6. Fatal or non-fatal AMI [ Time Frame: 1 year ]
  7. Coronary revascularization procedure [ Time Frame: 1 year ]
  8. Ischemic stroke [ Time Frame: 1 year ]
  9. Re-admission [ Time Frame: 1 year ]
  10. Adherence to medications for secondary prevention [ Time Frame: 1 year ]
    Taking the following medications for 6 or more days per week: aspirin, clopidogrel, ACEI/ARB, statin and beta-blockers

  11. Control of risk factors [ Time Frame: 1 year ]
    Control of hypertension, diabetes, dyslipidemia, smoking, and obesity

Other Outcome Measures:
  1. Cognitive function (MMSE) [ Time Frame: 1 year ]
  2. Sexual activity/function [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • Previously enrolled in the PEACE study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624922

China, Beijing
Fuwai Hospital
Beijing, Beijing, China, 100037
Sponsors and Collaborators
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
More Information

Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01624922     History of Changes
Other Study ID Numbers: WSGY-201202025-4
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases