View Clinical Trial (Medical Research Study)
The PACE-MI Registry Study
| City: |
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Oklahoma City |
| State: |
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Oklahoma |
| Zip Code: |
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73104 |
| Conditions: |
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Myocardial Infarction |
| Purpose: |
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The purpose of the PACE-MI 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 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.
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| Study Summary: |
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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 7,326 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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00430612 |
| Primary Contact: |
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Principal Investigator
Jeffrey Goldberger, MD, MBA
Northwestern University
Charity Ball, RN, BSN
Phone: 312-926-5517
Email: c-ball@northwestern.edu
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| Backup Contact: |
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Email: dlizcano@nmh.org
Daya Alexander, BA
Phone: 312-926-7299
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| Location Contact: |
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Oklahoma City, Oklahoma 73104
United States
Kathy Drennan
Phone: 405-271-8000
Email: kathy-drennan@ouhsc.edu
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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