China PEACE-Prospective PCI Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01624922
First received: June 17, 2012
Last updated: August 13, 2013
Last verified: August 2013

June 17, 2012
August 13, 2013
December 2012
August 2013   (final data collection date for primary outcome measure)
Major adverse cardiac events (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization.
Same as current
Complete list of historical versions of study NCT01624922 on ClinicalTrials.gov Archive Site
  • Coronary death or myocardial infarction (fatal or non-fatal MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Coronary revascularization procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Presumed ischemic stroke (i.e. not known to be hemorrhagic) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death from all cardiovascular causes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Re-admission [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Status of general health (SF-12) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of life (EQ-5D) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Symptoms status (SAQ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
China PEACE-Prospective PCI Study
The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Percutaneous Coronary Intervention

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

In 30 tertiary hospitals with capability of Percutaneous Coronary Intervention in China, 3000 hospitalized patients undergoing Percutaneous Coronary Intervention will be enrolled consecutively.

Coronary Heart Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2014
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Previously enrolled in the PEACE study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01624922
WSGY-201202025-4
Yes
China National Center for Cardiovascular Diseases
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
China National Center for Cardiovascular Diseases
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP