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

NCT ID: NCT00430612

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7057 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2015-10-31

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.

Conditions

Myocardial Infarction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

All Registry Participants

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

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Jeff Goldberger

Principal Investigator, MD, MBA, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Goldberger, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Little Rock Cardiology Clinic

Little Rock, Arkansas, United States

MemorialCare Heart and Vascular Institute - Long Beach Memorial Medical Center

Long Beach, California, United States

West Los Angeles VA Medical Center

Los Angeles, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Clarian Health/Methodist Research Institute

Indianapolis, Indiana, United States

Henry Ford Hospital

Detroit, Michigan, 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

OhioHealth Research Institute

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Amarillo Heart Clinic Research Institute, Inc.

Amarillo, Texas, United States

Austin Heart PLLC

Austin, Texas, United States

Providence Health Center

Waco, Texas, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

University of Calgary

Calgary, Alberta, Canada

Countries

United States; Canada

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Goldberger JJ, Bonow RO, Cuffe M, Liu L, Rosenberg Y, Shah PK, Smith SC Jr, Subacius H; OBTAIN Investigators. Effect of Beta-Blocker Dose on Survival After Acute Myocardial Infarction. J Am Coll Cardiol. 2015 Sep 29;66(13):1431-41. doi: 10.1016/j.jacc.2015.07.047.

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Other Identifiers

U01HL080416

Identifier Type: NIH

Identifier Source: secondary_id

View Link

469

Identifier Type: -

Identifier Source: org_study_id