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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— BLOCK2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04717492
• Other study ID #: 1512M81981-Observational
• Status: Completed
• Start date: June 28, 2020
• Est. completion date: December 2, 2022

Study information

• Verified date: February 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 current 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 information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: December 2, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	NewYork-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	The University of Vermont	Burlington	Vermont
United States	Northwestern University	Chicago	Illinois
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	New York Presbyterian/Queens	Flushing	New York
United States	University of California, San Francisco-Fresno	Fresno	California
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida
United States	LA BioMed at Harbor-UCLA Medical Center	Los Angeles	California
United States	HealthPartners Research Foundation	Minneapolis	Minnesota
United States	Veteran's Administration Medical Center	Minneapolis	Minnesota
United States	Louisiana State University	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Temple University Lung Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	University of California at San Francisco	San Francisco	California
United States	University of Washington School of Medicine	Spokane	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	United States Department of Defense, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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 cardiopulmonary outcomes.	6 Months