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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Jeff Goldberger, Northwestern University.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: February 2, 2007
Last Update Posted: May 1, 2015
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.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Myocardial Infarction

Study Type: Observational [Patient Registry]
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Jeff Goldberger, Northwestern University:

Primary Outcome Measures:
  • 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:
  • 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%)

Estimated Enrollment: 6830
Study Start Date: May 2009
Estimated Study Completion Date: June 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site

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.


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.

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00430612

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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Goldberger, Principal Investigator, MD, MBA, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT00430612     History of Changes
Other Study ID Numbers: 469
U01HL080416 ( U.S. NIH Grant/Contract )
R01 HL080416-01A1
First Submitted: January 31, 2007
First Posted: February 2, 2007
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:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

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