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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00430612 |
Purpose
The purpose of the PACE-MI registry is:
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.
| Condition |
|---|
|
Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The PACE-MI Registry Study |
| Estimated Enrollment: | 7326 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2012 (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
|
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:
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 |
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:
Contacts and Locations| Contact: Charity Ball, RN, BSN | 312-926-5517 | c-ball@northwestern.edu |
| Contact: Daya Alexander, BA | 312-926-7299 | dlizcano@nmh.org |
Show 21 Study Locations| Principal Investigator: | Jeffrey Goldberger, MD, MBA | Northwestern University |
More Information
| Responsible Party: | Jeffrey Goldberger, MD, MBA, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00430612 History of Changes |
| Other Study ID Numbers: | 469, R01 HL080416-01A1 |
| Study First Received: | January 31, 2007 |
| Last Updated: | January 26, 2011 |
| Health Authority: | United States: Federal Government |
|
Myocardial Infarction Heart Attack Beta Blockers Survival |
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |