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

NCT04717492 | Completed Results DMC

• 1 other identifier: 1512M81981-Observational
• Study Type: observational
• Target: 584
• Locations: 1 country
• Sites: 24

Brief Summary

The study is a prospective, observational study of patients admitted to the BLOCK COPD network hospitals with acute AMI and Chronic Obstructive Pulmonary Disease (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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Cardiac; Cardiovascular; Beta blockers; Acute Myocardial Infarction; Cardiac Catheterization

Outcome Measures

Primary Outcomes (12)

• 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

• Forced Expiratory Volume (FEV1), L; Post-bronchodilator

  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

• FEV1 % Predicted; Post-bronchodilator

  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

• Number of Participants With Prescriptions for Home Oxygen

  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

• Number of Participants That Received a Course of Systemic Corticosteroids and/or Antibiotics in Past Year

  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

• Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year

  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

• Respiratory Episodes Requiring Care in the Emergency Department in Past Year

  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

• Respiratory Episodes Leading to Hospitalization in Past Year

  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

• Number of Hospitalizations in Past Year

  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

• Respiratory Episodes Requiring Intubation in Past Year

  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

• Time to Death, or First Hospitalization or Revascularization Event

  Compare the time to death or all-cause hospitalization or revascularization event at 6 months for patients with AMI and COPD who were discharged alive on beta-blockers to that of patients not discharged on beta-blockers.

  6 month follow-up

• Risk of Death, Hospitalization or Revascularization Event

  Compare the risk of death or all-cause hospitalization at 6 months for patients with AMI and COPD who were discharged alive on beta-blockers to that of patients not discharged on beta-blockers by analyzing number of participants experiencing events. The number of participants will be reported for this outcome.

  6 month follow-up

Secondary Outcomes (4)

• Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event

  6 month follow-up

• Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event

  6 month follow-up

• Time to Respiratory/COPD-related Death or Hospitalization Event

  6 month follow-up

• Risk of Respiratory/COPD-related Death or Hospitalization Event

  6 month follow-up

Interventions

Observational OTHER

Observational

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Willing and able to provide informed consent (applicable for Option 1 and 2 only)
• Men and women age 35 or older
• Admitted to hospital from the Emergency Department or by hospital to hospital transfer with a primary diagnosis of AMI
• Undergo cardiac catheterization for AMI
• EMR-documented COPD

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead
• United States Department of Defense: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (24)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

LA BioMed at Harbor-UCLA Medical Center

Los Angeles, California, 90502, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Veteran's Administration Medical Center

Minneapolis, Minnesota, 55417, United States

Location

HealthPartners Research Foundation

Minneapolis, Minnesota, 55440, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

New York Presbyterian/Queens

Flushing, New York, 11355, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University Lung Center

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132-4701, United States

Location

The University of Vermont

Burlington, Vermont, 05405, United States

Location

University of Washington School of Medicine

Spokane, Washington, 99258, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Limitations and Caveats

Relatively small number of patients who were discharged without beta-blockers, which likely limited the power of our study to detect modest differences in outcomes. Only patients who underwent cardiac catheterization were included. Subsequent hospitalization events at facilities outside the BLOCK-COPD network may not have been captured if study staff were not notified of the event.

Results Point of Contact

• Title: Mark Dransfield
• Organization: UAB Lung Health Center

mdransfield@uabmc.edu

205-934-5425

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: June 28, 2020
• Primary Completion: May 18, 2022
• Study Completion: December 2, 2022
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2024-12

Locations

US (24)