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
|Condition or disease|
|Coronary Heart Disease|
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|
|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|
- 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.
- Symptoms status (SAQ) [ Time Frame: 1 year ]
- Quality of life (EQ-5D) [ Time Frame: 1 year ]
- Depression (PHQ-8) [ Time Frame: 1 year ]
- Stress (PSS-4) [ Time Frame: 1 year ]
- Cardiac death [ Time Frame: 1 year ]
- Fatal or non-fatal AMI [ Time Frame: 1 year ]
- Coronary revascularization procedure [ Time Frame: 1 year ]
- Ischemic stroke [ Time Frame: 1 year ]
- Re-admission [ Time Frame: 1 year ]
- 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
- Control of risk factors [ Time Frame: 1 year ]Control of hypertension, diabetes, dyslipidemia, smoking, and obesity
- Cognitive function (MMSE) [ Time Frame: 1 year ]
- 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.
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
|Beijing, Beijing, China, 100037|
|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|