China PEACE-Prospective AMI Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by China National Center for Cardiovascular Diseases
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01624909
First received: June 17, 2012
Last updated: February 5, 2014
Last verified: February 2014

June 17, 2012
February 5, 2014
December 2012
April 2014   (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 NCT01624909 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 AMI Study
The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Acute Myocardial Infarction

Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women, however little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about safety and efficacy of treatment for AMI is limited. By consecutively recruiting AMI patients in 40 hospitals of different levels, this study will examine various real-life factors, that may affect patients recovery after a heart attack. Practical guidelines and risk model for AMI patients 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 AMI is one of the leading causes of mortality and morbidity. Remarkable variations of resources available and health system performance have been noted, however little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about safety, efficacy, and effectiveness of treatment for AMI during long-term recovery is limited. 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 a confirmed diagnosis of AMI consecutively in 20 tertiary hospitals and 20 secondary 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. 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 a heart attack, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and risk model for AMI patients 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 40 hospitals of different levels in China, 4000 hospitalized patients with acute myocardial infarction 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.
 
Recruiting
4000
May 2015
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized patients with acute myocardial infarction according to positive cardiac biomarkers (Troponin I/T, CK-MB or CK≥ local laboratory upper limit of normal values within 24 hours after initial presentation, and at least one of the following two supporting evidence of ischemia (ischemic symptoms occurring within 24 hours before admission or up to 72 hours for STEMI; ECG changes indicative of new ischemia).

Exclusion Criteria:

  • Previously enrolled in the PEACE study
Both
18 Years and older
No
Contact: Lixin Jiang, M.D., Ph.D. 86-10-8836-2967 lixin.jiang@fwoxford.org
Contact: Xi Li, M.D., Ph.D. 86-10-8839-6082 ext 279 xi.li@fwoxford.org
China
 
NCT01624909
WSGY-201202025-3
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
February 2014

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