An Observational Study of Beta-Blocker Use in Patients With COPD and Acute MI
NCT ID: NCT04717492
Last Updated: 2025-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
584 participants
OBSERVATIONAL
2020-06-28
2022-12-02
Brief Summary
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Detailed Description
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Patients admitted to the hospital and who undergo cardiac catheterization for an AMI will be identified through the electronic medical record (EMR). Those with a diagnosis of COPD in the EMR will be offered participation in the study. Baseline characterization will include demographics, smoking history, prior history of exacerbations in the year before admission, supplemental oxygen use, respiratory and cardiac medication use, comorbidities including history of coronary artery disease, heart failure and ejection fraction, and pulmonary function data as available in the EMR. Results of this Aim will provide data about the prevalence and clinical characteristics of COPD in the hospitalized population with AMI in our network. The Aim will also provide an estimate of the number of annual admissions for patients with COPD and AMI.
Specific Aim 2. To determine the association between beta-blocker use at discharge and cardiopulmonary outcomes in patients with COPD and AMI.
Patients with AMI and EMR-documented COPD will be followed, prospectively from the time of discharge using review of the electronic medical record and as local guidance permits, phone calls at 3 and 6 months. The investigators will determine the associations between beta-blocker use at discharge and the risk for all-cause mortality, recurrent ischemic events, and hospitalization for COPD exacerbation adjusting for baseline characteristics and COPD severity.
Because of the coronavirus disease 2019(COVID-19) pandemic and the possibility of limited access to hospitalized patients, the study consists of three options for enrollment. Option 1 or 2 is preferable if local guidance permits.
Option 1: A total of 3 visits including 1 in person visit in the hospital and 2 follow up phone calls with EMR review at 3 and 6 months after discharge. Sites may consider alternatives to in person consent and data collection including by telephone or video conference.
Option 2: EMR review at the time of hospital admission followed by post-discharge telephone consent and 2 follow up phone calls with EMR review at 3 and 6 months.
Option 3: EMR review at the time of hospital admission and follow-up review of the EMR at 3 and 6 months after discharge.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Observational
Observational
Eligibility Criteria
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Inclusion Criteria
2. Men and women age 35 or older
3. Admitted to hospital from the Emergency Department or by hospital to hospital transfer with a primary diagnosis of AMI
4. Undergo cardiac catheterization for AMI
5. EMR-documented COPD
Exclusion Criteria
2. Vulnerable populations, including prisoners and pregnant women
35 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of Alabama at Birmingham
OTHER
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Mark Dransfield, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
John Connett, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Stephen Lazarus, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, San Francisco-Fresno
Fresno, California, United States
LA BioMed at Harbor-UCLA Medical Center
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
National Jewish Medical & Research Center
Denver, Colorado, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Louisiana State University
New Orleans, Louisiana, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Veteran's Administration Medical Center
Minneapolis, Minnesota, United States
HealthPartners Research Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
New York Presbyterian/Queens
Flushing, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Temple University Lung Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
The University of Vermont
Burlington, Vermont, United States
University of Washington School of Medicine
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1512M81981-Observational
Identifier Type: -
Identifier Source: org_study_id
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