China PEACE-Prospective AMI Study

This study is currently recruiting participants.
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
  Purpose

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.


Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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.


Estimated Enrollment: 4000
Study Start Date: December 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

In 40 hospitals of different levels in China, 4000 hospitalized patients with acute myocardial infarction will be enrolled consecutively.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624909

Contacts
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

Locations
China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Lixin Jiang, M.D., Ph.D.         
Principal Investigator: Lixin Jiang, M.D., Ph.D.         
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Ministry of Health, China
Investigators
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

No publications provided

Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01624909     History of Changes
Other Study ID Numbers: WSGY-201202025-3
Study First Received: June 17, 2012
Last Updated: February 5, 2014
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on April 14, 2014