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China PEACE-Prospective AMI Study

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ClinicalTrials.gov Identifier: NCT01624909
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : August 31, 2015
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

Brief Summary:
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 or disease
Coronary Heart Disease

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.


Study Type : Observational
Actual Enrollment : 4286 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Prospective Study of Acute Myocardial Infarction
Study Start Date : December 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2015



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.



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 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

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): NCT01624909


Locations
China, Beijing
Fuwai Hospital
Beijing, Beijing, China, 100037
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01624909     History of Changes
Other Study ID Numbers: WSGY-201202025-3
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
Arteriosclerosis
Arterial Occlusive Diseases