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

University of Minnesota (UMN)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Observational

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04717492

1512M81981-Observational

Details and patient eligibility

About

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.

Full 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.

Enrollment: 584 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design