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

An Observational Study of Beta-Blocker Use in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 584

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Fresno, California, United States, 93701
      • University of California, San Francisco-Fresno
    • Los Angeles, California, United States, 90502
      • LA Biomed at Harbor-UCLA Medical Center
    • San Francisco, California, United States, 94143
      • University of California at San Francisco
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Medical & Research Center
  • Florida
    • Gainesville, Florida, United States, 32608
      • North Florida/South Georgia Veterans Health System
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55440
      • HealthPartners Research Foundation
    • Minneapolis, Minnesota, United States, 55417
      • Veteran's Administration Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Brooklyn, New York, United States, 11215
      • NewYork-Presbyterian Brooklyn Methodist Hospital
    • Flushing, New York, United States, 11355
      • New York Presbyterian/Queens
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10027
      • Columbia University
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati VA Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Lung Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Utah
    • Salt Lake City, Utah, United States, 84132-4701
      • University of Utah Health Sciences Center
  • Vermont
    • Burlington, Vermont, United States, 05405
      • The University of Vermont
  • Washington
    • Spokane, Washington, United States, 99258
      • University of Washington School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects hospitalized and who undergo cardiac catheterization with AMI and have EMR-documented COPD.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of COPD in patients admitted to the hospital with an acute myocardial infarction (AMI)	Results of this Aim will provide data about the prevalence of COPD in the hospitalized population with AMI in our network.	Baseline
Characterize the phenotypic expression and severity of underlying lung disease.	Results of this Aim will provide data about the clinical characteristics of COPD in the hospitalized population with AMI in our network.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 cardiopulmonary outcomes.	6 Months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: University of Alabama at Birmingham; United States Department of Defense
• Investigators: Principal Investigator: John Connett, PhD, University of Minnesota; Principal Investigator: Stephen Lazarus, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2020
• Primary Completion (Actual): May 18, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; COPD; Cardiovascular; Chronic Obstructive Pulmonary Disease; Cardiac; Cardiac Catheterization; Beta blockers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1512M81981-Observational

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No