Clinical trial NCT04717492: An Observational Study of Beta-Blocker Use in Patients With COPD and Acute MI
Official title: An Observational Study of Beta-Blocker Use in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Cardiac
Cardiovascular
Beta blockers
Acute Myocardial Infarction
Cardiac Catheterization
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of Alabama at Birmingham
First posted: 2021-01-22
Enrollment: 584
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects hospitalized and who undergo cardiac catheterization with AMI and have EMR-documented COPD.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI)
timeFrame: Baseline
measure: Forced Expiratory Volume (FEV1), L; Post-bronchodilator
timeFrame: Baseline
measure: FEV1 % Predicted; Post-bronchodilator
timeFrame: Baseline
measure: Number of Participants With Prescriptions for Home Oxygen
timeFrame: Baseline
measure: Number of Participants That Received a Course of Systemic Corticosteroids and/or Antibiotics in Past Year
timeFrame: Baseline
measure: Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year
timeFrame: Baseline
measure: Respiratory Episodes Requiring Care in the Emergency Department in Past Year
timeFrame: Baseline
measure: Respiratory Episodes Leading to Hospitalization in Past Year
timeFrame: Baseline
measure: Number of Hospitalizations in Past Year
timeFrame: Baseline
measure: Respiratory Episodes Requiring Intubation in Past Year
timeFrame: Baseline
measure: Time to Death, or First Hospitalization or Revascularization Event
timeFrame: 6 month follow-up
measure: Risk of Death, Hospitalization or Revascularization Event
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
timeFrame: 6 month follow-up
measure: Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
timeFrame: 6 month follow-up
measure: Time to Respiratory/COPD-related Death or Hospitalization Event
timeFrame: 6 month follow-up
measure: Risk of Respiratory/COPD-related Death or Hospitalization Event
timeFrame: 6 month follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fresno
country: United States
facility: University of California, San Francisco-Fresno
state: California
city: Los Angeles
country: United States
facility: LA BioMed at Harbor-UCLA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Veteran's Administration Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: HealthPartners Research Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Flushing
country: United States
facility: New York Presbyterian/Queens
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Lung Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Burlington
country: United States
facility: The University of Vermont
state: Vermont
city: Spokane
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: University of Alabama at Birmingham
name: Mark Dransfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: John Connett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Stephen Lazarus, MD
role: PRINCIPAL_INVESTIGATOR
References: