The PACE-MI Registry Study
The purpose of the PACE-MI 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 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...
Brief Summary
Official Title: “The PACE-MI Registry Study”
The purpose of the PACE-MI 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 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.
- Study Type: Observational
- Study Design: Time Perspective: Prospective
- Study Primary Completion Date: September 2012
Detailed Clinical Trial 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 7,326 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.
Arms, Groups and Cohorts in this Clinical Trial
- : 1
- Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site
Outcome Measures for this Clinical Trial
Primary Measures
- Total mortality at 2 years post myocardial infarction
- Time Frame: Measured at Year 1 and Year 2
Safety Issue?: No
- Time Frame: Measured at Year 1 and Year 2
Secondary Measures
- Compare Kaplan Meier survival curves for the following 2 beta-blocker dose groups: Very Low Dose (0 - 25%) Full Dose (>50%)
- Time Frame: Measured at Year 1 and Year 2
Safety Issue?: No
- Time Frame: Measured at Year 1 and Year 2
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Heart, Lung, and Blood Institute (NHLBI) NIH
Overall Clinical Trial Officials and Contacts
Jeffrey Goldberger, MD, MBA Principal Investigator Northwestern University
Overall Contact: Charity Ball, RN, BSN 312-926-5517 c-ball@northwestern.edu
Related Publications
References
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Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00430612
Study ID Number: 469
ClinicalTrials.gov Identifier: NCT00430612
Health Authority: United States: Federal Government
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The URL of this page is:
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