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

Sponsor

Northwestern University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00430612

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

6,830

Enrollment

Locations

Duration (Months)

297

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Myocardial Infarction

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

6830 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
1 Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site

Outcome Measures

Primary Outcome Measures

Total mortality at 2 years post myocardial infarction [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 [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%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Consecutive patients admitted with a myocardial infarction documented by both of the following:
cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab)
Electrocardiographic changes and/or symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath)

No Exclusion Criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Little Rock Cardiology Clinic	Little Rock	Arkansas	United States	72211
2	MemorialCare Heart and Vascular Institute - Long Beach Memorial Medical Center	Long Beach	California	United States	90806
3	West Los Angeles VA Medical Center	Los Angeles	California	United States	90073
4	Bridgeport Hospital	Bridgeport	Connecticut	United States	06610
5	Baptist Cardiac and Vascular Institute	Miami	Florida	United States	33176
6	Orlando Regional Medical Center	Orlando	Florida	United States	32806
7	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
8	Clarian Health/Methodist Research Institute	Indianapolis	Indiana	United States	46202
9	Henry Ford Hospital	Detroit	Michigan	United States	48202
10	Park Nicollet	St. Louis Park	Minnesota	United States	55426
11	Winthrop University Hospital	Bethpage	New York	United States	11714
12	Maimonides Medical Center	Brooklyn	New York	United States	11219
13	Strong Memorial Hospital (University of Rochester School of Medicine)	Rochester	New York	United States	14642
14	OhioHealth Research Institute	Colombus	Ohio	United States	43214
15	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
16	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
17	Rhode Island Hospital	Providence	Rhode Island	United States	02903
18	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
19	Amarillo Heart Clinic Research Institute, Inc.	Amarillo	Texas	United States	79106
20	Austin Heart PLLC	Austin	Texas	United States	78756
21	Providence Health Center	Waco	Texas	United States	76712
22	Fletcher Allen Health Care	Burlington	Vermont	United States	05401
23	University of Calgary	Calgary	Alberta	Canada	T2N 4N1