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An Observational Study of Beta-Blocker Use in Patients With COPD and Acute MI (BLOCK2)

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ClinicalTrials.gov Identifier: NCT04717492
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborators:
United States Department of Defense
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The study is a prospective, observational study of patients admitted to the BLOCK COPD network hospitals with acute AMI and COPD to determine the prevalence of COPD in patients admitted to the hospital with an acute myocardial infarction (AMI) and to characterize the phenotypic expression and severity of their underlying lung disease. Patients with will be identified via the EMR. 571 participants will be enrolled.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: Observational

Detailed Description:

Specific Aim 1. To determine the prevalence of COPD in patients admitted to the hospital with an acute myocardial infarction (AMI) and to characterize the phenotypic expression and severity of their underlying lung disease.

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 current 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.

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Study Type : Observational
Estimated Enrollment : 571 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Beta-Blocker Use in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Myocardial Infarction
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Observational
    Observational


Primary Outcome Measures :
  1. Prevalence of COPD in patients admitted to the hospital with an acute myocardial infarction (AMI) [ Time Frame: Baseline ]
    Results of this Aim will provide data about the prevalence of COPD in the hospitalized population with AMI in our network.

  2. Characterize the phenotypic expression and severity of underlying lung disease. [ Time Frame: Baseline ]
    Results of this Aim will provide data about the clinical characteristics of COPD in the hospitalized population with AMI in our network.


Secondary Outcome Measures :
  1. Association between beta-blocker use at discharge and cardiopulmonary outcomes in patients with COPD and AMI. [ Time Frame: 6 Months ]
    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 cardiopulmonary outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects hospitalized and who undergo cardiac catheterization with AMI and have EMR-documented COPD.
Criteria

Inclusion Criteria:

  1. Willing and able to provide informed consent (applicable for Option 1 and 2 only)
  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:

  1. Cognitive disorder that in the judgment of the investigator impairs understanding of the study objectives or assessments (applicable for Option 1 only)
  2. Vulnerable populations, including prisoners and pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717492


Contacts
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Contact: Mark Dransfield, MD 205-986-0101 mdransfield@uabmc.edu
Contact: Sarah Lindberg, MPH 612-626-9011 slindberg@umn.edu

Locations
Show Show 24 study locations
Sponsors and Collaborators
University of Minnesota
United States Department of Defense
University of Alabama at Birmingham
Investigators
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Principal Investigator: Mark Dransfield, MD University of Alabama at Birmingham
Principal Investigator: John Connett, PhD University of Minnesota
Principal Investigator: Stephen Lazarus, MD University of California, San Francisco
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04717492    
Other Study ID Numbers: 1512M81981-Observational
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Chronic Obstructive Pulmonary Disease
COPD
Cardiac
Cardiovascular
Beta blockers
Acute Myocardial Infarction
Cardiac Catheterization
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive