Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Cardiac, Cardiovascular, Beta blockers, Acute Myocardial Infarction, Cardiac Catheterization
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.
Interventions
OTHERObservational
Observational
Sponsors
United States Department of Defense
University of Alabama at Birmingham
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients admitted to the hospital and who undergo cardiac catheterization for an AMI were identified through the electronic medical record (EMR). Patients with EMR-documented Chronic Obstructive Pulmonary Disease (COPD) that were discharged alive were followed, prospectively from the time of discharge using review of the electronic medical record and as local guidance permitted, phone calls at 3 and 6 months. Comparisons of participants discharged with a beta
Pre-assignment details
This is an observational study. Participants that were discharged alive were categorized based on whether they had a beta blocker prescription at discharge.
Participants by arm
| Arm | Count |
|---|---|
| Not Discharged With Beta Blockers Participants discharged without a beta blocker prescription | 77 |
| Discharged With Beta Blockers Participants discharged with a beta blocker prescription | 502 |
| Total | 579 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 13 |
Baseline characteristics
| Characteristic | Not Discharged With Beta Blockers | Discharged With Beta Blockers | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 70 years | 70 years |
| Anxiety | 32 Participants | 121 Participants | 153 Participants |
| Asthma | 17 Participants | 87 Participants | 104 Participants |
| BMI | 27.0 kg/m^2 | 28.0 kg/m^2 | 27.7 kg/m^2 |
| Cancer | 14 Participants | 110 Participants | 124 Participants |
| Cirrhosis | 3 Participants | 23 Participants | 26 Participants |
| Coronary artery bypass grafting | 15 Participants | 103 Participants | 118 Participants |
| Coronary artery disease | 41 Participants | 344 Participants | 385 Participants |
| Depression | 27 Participants | 123 Participants | 150 Participants |
| Diabetes mellitus | 32 Participants | 205 Participants | 237 Participants |
| End stage renal disease | 5 Participants | 33 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 13 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 483 Participants | 558 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 7 Participants |
| Heart attack | 34 Participants | 243 Participants | 277 Participants |
| Heart failure | 25 Participants | 189 Participants | 214 Participants |
| High blood pressure | 67 Participants | 454 Participants | 521 Participants |
| Hyperlipidemia | 61 Participants | 411 Participants | 472 Participants |
| Obstructive sleep apnea | 21 Participants | 122 Participants | 143 Participants |
| Organ transplantation | 3 Participants | 7 Participants | 10 Participants |
| Percutaneous coronary intervention | 30 Participants | 255 Participants | 285 Participants |
| Peripheral vascular disease | 16 Participants | 120 Participants | 136 Participants |
| Race/Ethnicity, Customized Black | 11 Participants | 68 Participants | 79 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 13 Participants | 14 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 18 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 403 Participants | 464 Participants |
| Sex: Female, Male Female | 35 Participants | 208 Participants | 243 Participants |
| Sex: Female, Male Male | 42 Participants | 294 Participants | 336 Participants |
| Smoking status Current smoker | 24 Participants | 188 Participants | 212 Participants |
| Smoking status Former smoker | 46 Participants | 279 Participants | 325 Participants |
| Smoking status Never smoker | 7 Participants | 35 Participants | 42 Participants |
| Stroke | 17 Participants | 63 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 73 | 48 / 480 |
| other Total, other adverse events | 14 / 73 | 82 / 480 |
| serious Total, serious adverse events | 29 / 73 | 163 / 480 |
Outcome results
Primary
FEV1 % Predicted; Post-bronchodilator
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 frame: Baseline
Population: Based on participants with spirometry data available in their medical records in the 3 years prior to their admission.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | FEV1 % Predicted; Post-bronchodilator | 51.5 Percent predicted |
| Discharged With Beta Blockers | FEV1 % Predicted; Post-bronchodilator | 67.0 Percent predicted |
Primary
Forced Expiratory Volume (FEV1), L; Post-bronchodilator
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 frame: Baseline
Population: Based on participants with spirometry data available in their medical records in the 3 years prior to their admission.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Forced Expiratory Volume (FEV1), L; Post-bronchodilator | 1.6 Liters |
| Discharged With Beta Blockers | Forced Expiratory Volume (FEV1), L; Post-bronchodilator | 1.7 Liters |
Primary
Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year
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 frame: Baseline
Population: Based on participant self report or from electronic medical records if consent not obtained. Median and range reported based on those who received a course of systemic corticosteroids and/or antibiotics in past year.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year | 1.0 COPD exacerbation treatment courses |
| Discharged With Beta Blockers | Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year | 1.0 COPD exacerbation treatment courses |
Primary
Number of Hospitalizations in Past Year
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 frame: Baseline
Population: Based on participant self report or from electronic medical records if consent not obtained. Median and range reported based on those who had respiratory episodes leading to hospitalization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Number of Hospitalizations in Past Year | 1.0 number of hospitalizations |
| Discharged With Beta Blockers | Number of Hospitalizations in Past Year | 1.0 number of hospitalizations |
Primary
Number of Participants That Received a Course of Systemic Corticosteroids and/or Antibiotics in Past Year
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 frame: Baseline
Population: Based on participant self report or from electronic medical records if consent not obtained.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Number of Participants That Received a Course of Systemic Corticosteroids and/or Antibiotics in Past Year | 21 Participants |
| Discharged With Beta Blockers | Number of Participants That Received a Course of Systemic Corticosteroids and/or Antibiotics in Past Year | 111 Participants |
Primary
Number of Participants With Prescriptions for Home Oxygen
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 frame: Baseline
Population: Based on participant self report or from electronic medical records if consent not obtained.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Number of Participants With Prescriptions for Home Oxygen | 16 Participants |
| Discharged With Beta Blockers | Number of Participants With Prescriptions for Home Oxygen | 78 Participants |
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.
Time frame: Baseline
Population: Patients who underwent cardiac catheterization for AMI with self-reported or physician-documented COPD and enrolled in the study compared with patients who underwent cardiac catheterization for AMI without self-reported or physician-documented COPD that were screened but not enrolled for follow-up.~562 participants had COPD out of those screened. Participants were excluded from two sites that screened only patients with COPD.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI) | 562 Participants |
Primary
Respiratory Episodes Leading to Hospitalization in Past Year
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 frame: Baseline
Population: Based on participant self report or from electronic medical records if consent not obtained.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Respiratory Episodes Leading to Hospitalization in Past Year | 10 episodes |
| Discharged With Beta Blockers | Respiratory Episodes Leading to Hospitalization in Past Year | 56 episodes |
Primary
Respiratory Episodes Requiring Care in the Emergency Department in Past Year
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 frame: Baseline
Population: Based on participant self report or from electronic medical records if consent not obtained.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Respiratory Episodes Requiring Care in the Emergency Department in Past Year | 11 episodes |
| Discharged With Beta Blockers | Respiratory Episodes Requiring Care in the Emergency Department in Past Year | 69 episodes |
Primary
Respiratory Episodes Requiring Intubation in Past Year
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 frame: Baseline
Population: Based on participant self report or from electronic medical records if consent not obtained.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Respiratory Episodes Requiring Intubation in Past Year | 0 episodes |
| Discharged With Beta Blockers | Respiratory Episodes Requiring Intubation in Past Year | 4 episodes |
Primary
Risk of Death, Hospitalization or Revascularization Event
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.
Time frame: 6 month follow-up
Population: Based on participant self report if consent obtained and from electronic medical records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Risk of Death, Hospitalization or Revascularization Event | 35 Participants |
| Discharged With Beta Blockers | Risk of Death, Hospitalization or Revascularization Event | 195 Participants |
Primary
Time to Death, or First Hospitalization or Revascularization Event
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.
Time frame: 6 month follow-up
Population: Based on participant self report if consent obtained and from electronic medical records.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Time to Death, or First Hospitalization or Revascularization Event | 19 days |
| Discharged With Beta Blockers | Time to Death, or First Hospitalization or Revascularization Event | 37.5 days |
Comparison: Time to death, or first hospitalization or revascularization event was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.p-value: 0.96295% CI: [0.66, 1.54]Regression, Cox
Secondary
Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
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 frame: 6 month follow-up
Population: Based on participant self report if consent obtained and from electronic medical records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event | 20 Participants |
| Discharged With Beta Blockers | Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event | 114 Participants |
Secondary
Risk of Respiratory/COPD-related Death or Hospitalization Event
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.
Time frame: 6 month follow-up
Population: Based on participant self report if consent obtained and from electronic medical records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Risk of Respiratory/COPD-related Death or Hospitalization Event | 10 Participants |
| Discharged With Beta Blockers | Risk of Respiratory/COPD-related Death or Hospitalization Event | 45 Participants |
Secondary
Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
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.
Time frame: 6 month follow-up
Population: Based on participant self report if consent obtained and from electronic medical records.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event | 23.5 days |
| Discharged With Beta Blockers | Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event | 37.5 days |
Comparison: Time to CVD-related death or hospitalization/revascularization was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.p-value: 0.69495% CI: [0.65, 1.92]Regression, Cox
Secondary
Time to Respiratory/COPD-related Death or Hospitalization Event
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.
Time frame: 6 month follow-up
Population: Based on participant self report if consent obtained and from electronic medical records.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Underwent Cardiac Catheterization for AMI | Time to Respiratory/COPD-related Death or Hospitalization Event | 93 dats |
| Discharged With Beta Blockers | Time to Respiratory/COPD-related Death or Hospitalization Event | 61 dats |
Comparison: Time to respiratory/COPD-related death or hospitalization was analyzed using Cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.p-value: 0.47695% CI: [0.34, 1.66]Regression, Cox