The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN) (OBTAIN)

April 20, 2023 updated by: Jeff Goldberger, Northwestern University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

7057

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Little Rock Cardiology Clinic
    • California
      • Long Beach, California, United States, 90806
        • MemorialCare Heart and Vascular Institute - Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90073
        • West Los Angeles VA Medical Center
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Cardiac and Vascular Institute
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Clarian Health/Methodist Research Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet
    • New York
      • Bethpage, New York, United States, 11714
        • Winthrop University Hospital
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital (University of Rochester School of Medicine)
    • Ohio
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
    • Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo Heart Clinic Research Institute, Inc.
      • Austin, Texas, United States, 78756
        • Austin Heart PLLC
      • Waco, Texas, United States, 76712
        • Providence Health Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

non-voluntary registry of consecutive patients diagnosed as having a MI at each study site

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
All Registry Participants
Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total mortality at 2 years post myocardial infarction
Time Frame: 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%)
Measured at Years 1 and 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total mortality - secondary analysis
Time Frame: 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%)
Measured at Year 1 and Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Jeffrey Goldberger, MD, MBA, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 469
  • U01HL080416 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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