Summary

Eligibility
for people ages 35 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Stephen Lazarus, MD
Photo of Stephen Lazarus
Stephen Lazarus

Description

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.

Official Title

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

Details

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.

Keywords

Pulmonary Disease, Chronic Obstructive Chronic Obstructive Pulmonary Disease COPD Cardiac Cardiovascular Beta blockers Acute Myocardial Infarction Cardiac Catheterization Lung Diseases

Eligibility

You can join if…

Open to people ages 35 years and up

  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

You CAN'T join if...

  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

Locations

  • University of California, San Francisco-Fresno not yet accepting patients
    Fresno California 93701 United States
  • University of California at San Francisco not yet accepting patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Stephen Lazarus, MD
    Dr. Lazarus is an inbred product of the University of California, having received his A.B. from Berkeley, his M.D. from Irvine, and training in Internal Medicine and Pulmonary & Critical Care Medicine at UCSF. Drafted into military service during the Viet Nam era, he spent 2 years as Chief of Pulmonary Medicine and Co-Director of the ICU at Andrews Air Force Base in Washington, D.C.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Minnesota
ID
NCT04717492
Study Type
Observational
Last Updated