The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)
- Conditions
- Myocardial Infarction
- Registration Number
- NCT00430612
- Lead Sponsor
- Northwestern University
- Brief Summary
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.
- Detailed 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. 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 is provided.
Data collected at follow-up interview will include vital status, beta-blocker use, other cardiac medications and any cardiovascular hospitalizations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7057
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total mortality at 2 years post myocardial infarction Measured at Years 1 and 2 Compare Kaplan Meier survival curves for the following 5 beta-blocker dose groups:
No beta-blockers - 12.5% (\>0 - 12.5%) 25% (\>12.5 - 25%) - 50% (\>25 - 50%) Full Dose (\>50%)
- Secondary Outcome Measures
Name Time Method Total mortality - secondary analysis Measured at Year 1 and Year 2 Compare Kaplan-Meier survival curves for the following 2 beta-blocker dose groups:
Very Low Dose (\>0-25%) vs. High Dose (≥50%)
Trial Locations
- Locations (23)
West Los Angeles VA Medical Center
🇺🇸Los Angeles, California, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Clarian Health/Methodist Research Institute
🇺🇸Indianapolis, Indiana, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Little Rock Cardiology Clinic
🇺🇸Little Rock, Arkansas, United States
MemorialCare Heart and Vascular Institute - Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Baptist Cardiac and Vascular Institute
🇺🇸Miami, Florida, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Park Nicollet
🇺🇸Saint Louis Park, Minnesota, United States
Winthrop University Hospital
🇺🇸Bethpage, New York, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Strong Memorial Hospital (University of Rochester School of Medicine)
🇺🇸Rochester, New York, United States
Amarillo Heart Clinic Research Institute, Inc.
🇺🇸Amarillo, Texas, United States
Providence Health Center
🇺🇸Waco, Texas, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Austin Heart PLLC
🇺🇸Austin, Texas, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States