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Completed

NCT Number: NCT04717492

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

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.

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Key information

Conditions

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

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Observational

Other

Observational

Primary outcomes

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

    Time frame: 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.

  3. FEV1 % Predicted; Post-bronchodilator

    Time frame: 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.

  4. Number of Participants With Prescriptions for Home Oxygen

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  7. Respiratory Episodes Requiring Care in the Emergency Department in Past Year

    Time frame: 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.

  8. Respiratory Episodes Leading to Hospitalization in Past Year

    Time frame: 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.

  9. Number of Hospitalizations in Past Year

    Time frame: 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.

  10. Respiratory Episodes Requiring Intubation in Past Year

    Time frame: 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.

  11. Time to Death, or First Hospitalization or Revascularization Event

    Time frame: 6 month follow-up

    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.

  12. Risk of Death, Hospitalization or Revascularization Event

    Time frame: 6 month follow-up

    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.

Secondary outcomes

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

    Time frame: 6 month follow-up

    Compare the time to first CVD-related event (revascularization, CVD-related hospitalization, or CVD-related death) 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 and time to first event.

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

    Time frame: 6 month follow-up

    Compare the risk of CVD-related event (revascularization, CVD-related hospitalization, or CVD-related death) 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 and time to first event.

  3. Time to Respiratory/COPD-related Death or Hospitalization Event

    Time frame: 6 month follow-up

    Compare the time to respiratory/COPD-related death or hospitalization for patients with AMI and COPD who were discharged alive on beta-blockers to that of patients not discharged on beta-blockers by analyzing the time to first event.

  4. Risk of Respiratory/COPD-related Death or Hospitalization Event

    Time frame: 6 month follow-up

    Compare the risk of respiratory/COPD-related death or hospitalization for patients with AMI and COPD who were discharged alive on beta-blockers to that of patients not discharged on beta-blockers by analyzing the number of of participants experiencing events.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • United States Department of Defense
  • University of Alabama at Birmingham

Registry information

Official study title

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

Acronym: BLOCK2

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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