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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430612
Recruitment Status : Unknown
Verified April 2015 by Jeff Goldberger, Northwestern University.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2007
Last Update Posted : May 1, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeff Goldberger, 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.

Condition or disease
Myocardial Infarction

Detailed Description:


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 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6830 participants
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)
Study Start Date : May 2009
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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

Primary Outcome Measures :
  1. 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%)

Secondary Outcome Measures :
  1. 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%)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430612

Show Show 23 study locations
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Jeffrey Goldberger, MD, MBA Northwestern University
Additional Information:

American Heart Association. Heart disease and stroke statistics-2009 update. Dallas: American Heart Association; 2009.
Dmitrienko A, Molenberghs G, Chuang-Stein C, Offen W. Analysis of clinical trials using SAS: A practical guide. Cary, NC: SAS Institute Inc.; 2005.
Westfall PH. Multiple comparisons and multiple tests : using the SAS system. 1. print. ed. Cary NC: SAS Inst.; 1999.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jeff Goldberger, Principal Investigator, MD, MBA, Professor of Medicine, Northwestern University Identifier: NCT00430612    
Other Study ID Numbers: 469
U01HL080416 ( U.S. NIH Grant/Contract )
R01 HL080416-01A1
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Jeff Goldberger, Northwestern University:
Myocardial Infarction
Heart Attack
Beta Blockers
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases