An Observational Study of Beta-Blocker Use in Patients With COPD and Acute MI
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT04717492
- Lead Sponsor
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 584
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI) Baseline Results of this Aim will provide data about the prevalence of COPD in the hospitalized population with AMI in our network.
Forced Expiratory Volume (FEV1), L; Post-bronchodilator 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.
FEV1 % Predicted; Post-bronchodilator 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.
Number of Participants With Prescriptions for Home Oxygen 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.
Number of Participants That Received a Course of Systemic Corticosteroids and/or Antibiotics in Past Year 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.
Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year 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.
Respiratory Episodes Requiring Care in the Emergency Department in Past Year 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.
Respiratory Episodes Leading to Hospitalization in Past Year 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.
Number of Hospitalizations in Past Year 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.
Respiratory Episodes Requiring Intubation in Past Year 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.
Time to Death, or First Hospitalization or Revascularization Event 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.
Risk of Death, Hospitalization or Revascularization Event 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 Outcome Measures
Name Time Method Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event 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.
Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event 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.
Time to Respiratory/COPD-related Death or Hospitalization Event 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.
Risk of Respiratory/COPD-related Death or Hospitalization Event 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.
Trial Locations
- Locations (24)
Northwestern University
🇺🇸Chicago, Illinois, United States
Cincinnati VA Medical Center
🇺🇸Cincinnati, Ohio, United States
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
North Florida/South Georgia Veterans Health System
🇺🇸Gainesville, Florida, United States
Louisiana State University
🇺🇸New Orleans, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Maryland Baltimore
🇺🇸Baltimore, Maryland, 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
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Temple University Lung Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Vermont
🇺🇸Burlington, Vermont, United States
University of Washington School of Medicine
🇺🇸Spokane, Washington, United States
HealthPartners Research Foundation
🇺🇸Minneapolis, Minnesota, United States
Veteran's Administration Medical Center
🇺🇸Minneapolis, Minnesota, United States
National Jewish Medical & Research Center
🇺🇸Denver, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States