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

Myocardial Infarction Clinical Trial

— OBTAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430612
• Other study ID #: 469
• Secondary ID: U01HL080416
• Status: Completed
• Start date: May 2009
• Est. completion date: October 2015

Study information

• Verified date: April 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 7057
• Est. completion date: October 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
United States	Amarillo Heart Clinic Research Institute, Inc.	Amarillo	Texas
United States	Austin Heart PLLC	Austin	Texas
United States	Winthrop University Hospital	Bethpage	New York
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Maimonides Medical Center	Brooklyn	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Clarian Health/Methodist Research Institute	Indianapolis	Indiana
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	West Los Angeles VA Medical Center	Los Angeles	California
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Orlando Regional Medical Center	Orlando	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Strong Memorial Hospital (University of Rochester School of Medicine)	Rochester	New York
United States	Park Nicollet	Saint Louis Park	Minnesota
United States	Providence Health Center	Waco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total mortality at 2 years post myocardial infarction	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	Total mortality - secondary analysis	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