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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeff Goldberger, Northwestern University
ClinicalTrials.gov Identifier:
NCT00430612
First received: January 31, 2007
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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
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 Northwestern University:

Primary Outcome Measures:
  • Total mortality at 2 years post myocardial infarction [ Time Frame: Measured at Years 1 and 2 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site

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 (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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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

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)

No Exclusion Criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430612

  Show 23 Study Locations
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeffrey Goldberger, MD, MBA Northwestern University
  More Information

Publications:

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, R01 HL080416-01A1
Study First Received: January 31, 2007
Last Updated: January 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
Myocardial Infarction
Heart Attack
Beta Blockers
Survival

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014