The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)
This trial is active, not recruiting.
|Collaborator||National Heart, Lung, and Blood Institute (NHLBI)|
|Start date||May 2009|
|End date||December 2013|
|Trial size||6830 participants|
|Trial identifier||NCT00430612, 469, R01 HL080416-01A1, U01HL080416|
The purpose of the PACE-MI (OBTAIN) registry is:
- Analyze beta-blocker dose response effect on outcome over two years
- Explore gender and minority differences in beta-blocker utilization and outcomes.
In patients with Myocardial Infarction (MI) discharged from the hospital, beta-blocker dose will be predictive of survival.
Exploratory analyses: Gender and racial effects—gender and race are, similarly, hypothesized to be predictive of post-MI survival.
The existence of interactions between gender and beta-blocker effect as well as race and beta-blocker effect will also be evaluated.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Little Rock, AR||Little Rock Cardiology Clinic||no longer recruiting|
|Long Beach, CA||MemorialCare Heart and Vascular Institute - Long Beach Memorial Medical Center||no longer recruiting|
|Los Angeles, CA||West Los Angeles VA Medical Center||no longer recruiting|
|Bridgeport, CT||Bridgeport Hospital||no longer recruiting|
|Miami, FL||Baptist Cardiac and Vascular Institute||no longer recruiting|
|Orlando, FL||Orlando Regional Medical Center||no longer recruiting|
|Chicago, IL||Northwestern Memorial Hospital||no longer recruiting|
|Indianapolis, IN||Clarian Health/Methodist Research Institute||no longer recruiting|
|Detroit, MI||Henry Ford Hospital||no longer recruiting|
|St. Louis Park, MN||Park Nicollet||no longer recruiting|
|Bethpage, NY||Winthrop University Hospital||no longer recruiting|
|Brooklyn, NY||Maimonides Medical Center||no longer recruiting|
|Rochester, NY||Strong Memorial Hospital (University of Rochester School of Medicine)||no longer recruiting|
|Colombus, OH||OhioHealth Research Institute||no longer recruiting|
|Oklahoma City, OK||University of Oklahoma Health Sciences Center||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Medical Center||no longer recruiting|
|Providence, RI||Rhode Island Hospital||no longer recruiting|
|Memphis, TN||Baptist Memorial Hospital||no longer recruiting|
|Amarillo, TX||Amarillo Heart Clinic Research Institute, Inc.||no longer recruiting|
|Austin, TX||Austin Heart PLLC||no longer recruiting|
|Waco, TX||Providence Health Center||no longer recruiting|
|Burlington, VT||Fletcher Allen Health Care||no longer recruiting|
|Calgary, Canada||University of Calgary||no longer recruiting|
Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site
Total mortality at 2 years post myocardial infarction
time frame: Measured at Years 1 and 2
Total mortality - secondary analysis
time frame: Measured at Year 1 and Year 2
Male or female participants at least 30 years old.
Inclusion Criteria 1. Consecutive patients admitted with a myocardial infarction documented by both of the following: 1. cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab) 2. Electrocardiographic changes and/or symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath) No Exclusion Criteria
|Official title||The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)|
|Principal investigator||Jeffrey Goldberger, MD, MBA|
|Description||Methods All patients admitted to the coronary care areas with an acute myocardial infarction will be entered into the registry. At the time of discharge from the coronary care unit, clinical data will be entered. The registry will include approximately 6800 patients. As there is no intervention in the registry, the data to be collected are standard for quality assurance purposes and cannot practicably be carried out without waivers of consent and HIPAA authorization, there will be no consent specifically for registry patients at baseline. Systems have been implemented to ensure the registry data will remain confidential. Sites have received IRB approval of waiver of consent and HIPAA for the baseline registry data. Data to be collected will include demographic (including ethnic and race classifications according to NIH guidelines) data and information regarding the index myocardial infarction. Use of beta-blockers at discharge from the coronary care unit will be documented. In addition, beta-blocker use at hospital discharge will be noted. Data for the registry will be obtained from ER notes, admission notes, cardiac catheterization lab reports, medication lists, lab reports, and discharge summaries. Follow-Up Follow-up for registry patients will be conducted at year 1 and year 2 post-myocardial infarction. Data may be obtained via medical chart review, phone contact, and Social Security Death Index (SSDI). For follow-up information obtained via chart review or the SSDI, a detailed justification for waiver of HIPAA and consent requirements is attached to this protocol (see appendix 7). If phone contact is required with the patient, we are suggesting the following process: - A letter should be sent out to the patient approximately one week prior to the contact in which the rationale for the study will be provided, as well as a delineation of the patient's right to participate or not to participate (by either providing or not providing the requested information). - At telephone contact with the patient, the coordinator will document whether the patient consents to provide the information. If the patient consents, the coordinator will proceed to obtain the requested information. - In the event that the participating institution's IRB requires a written, signed consent for this verbal contact, a written consent form template (see appendix 3) is provided. Data collected at follow-up interview will include vital status, beta-blocker use, other cardiac medications and any cardiovascular hospitalizations.|
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