Patient-centered Evaluative Assessment of Cardiac Events: Prospective Study of Acute Myocardial Infarction (PEACE-P-AMI)
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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: | Patient-centered Evaluative Assessment of Cardiac Events: Prospective Study of Patients With Acute Myocardial Infarction |
- 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.
- 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: | July 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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 |
In 40 hospitals of different levels in China, 4000 hospitalized patients with acute myocardial infarction will be enrolled consecutively.
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| 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 |
| 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: | June 19, 2012 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Infarction Myocardial Infarction Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 21, 2013