Trial Outcomes & Findings for An Observational Study of Beta-Blocker Use in Patients With COPD and Acute MI (NCT NCT04717492)
NCT ID: NCT04717492
Last Updated: 2025-01-31
Results Overview
Results of this Aim will provide data about the prevalence of COPD in the hospitalized population with AMI in our network.
COMPLETED
584 participants
Baseline
2025-01-31
Participant Flow
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
This is an observational study. Participants that were discharged alive were categorized based on whether they had a beta blocker prescription at discharge.
Participant milestones
| Measure |
Not Discharged With Beta Blockers
Participants discharged without a beta blocker prescription
|
Discharged With Beta Blockers
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
502
|
|
Overall Study
COMPLETED
|
73
|
480
|
|
Overall Study
NOT COMPLETED
|
4
|
22
|
Reasons for withdrawal
| Measure |
Not Discharged With Beta Blockers
Participants discharged without a beta blocker prescription
|
Discharged With Beta Blockers
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
13
|
|
Overall Study
Lost to Follow-up
|
2
|
9
|
Baseline Characteristics
An Observational Study of Beta-Blocker Use in Patients With COPD and Acute MI
Baseline characteristics by cohort
| Measure |
Not Discharged With Beta Blockers
n=77 Participants
Participants discharged without a beta blocker prescription
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
Total
n=579 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=99 Participants
|
70 years
n=107 Participants
|
70 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
208 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
294 Participants
n=107 Participants
|
336 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=99 Participants
|
483 Participants
n=107 Participants
|
558 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=99 Participants
|
403 Participants
n=107 Participants
|
464 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
BMI
|
27.0 kg/m^2
n=99 Participants
|
28.0 kg/m^2
n=107 Participants
|
27.7 kg/m^2
n=206 Participants
|
|
Smoking status
Current smoker
|
24 Participants
n=99 Participants
|
188 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
Smoking status
Former smoker
|
46 Participants
n=99 Participants
|
279 Participants
n=107 Participants
|
325 Participants
n=206 Participants
|
|
Smoking status
Never smoker
|
7 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
High blood pressure
|
67 Participants
n=99 Participants
|
454 Participants
n=107 Participants
|
521 Participants
n=206 Participants
|
|
Hyperlipidemia
|
61 Participants
n=99 Participants
|
411 Participants
n=107 Participants
|
472 Participants
n=206 Participants
|
|
Coronary artery disease
|
41 Participants
n=99 Participants
|
344 Participants
n=107 Participants
|
385 Participants
n=206 Participants
|
|
Heart attack
|
34 Participants
n=99 Participants
|
243 Participants
n=107 Participants
|
277 Participants
n=206 Participants
|
|
Heart failure
|
25 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Percutaneous coronary intervention
|
30 Participants
n=99 Participants
|
255 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
|
Coronary artery bypass grafting
|
15 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Peripheral vascular disease
|
16 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Stroke
|
17 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Diabetes mellitus
|
32 Participants
n=99 Participants
|
205 Participants
n=107 Participants
|
237 Participants
n=206 Participants
|
|
Cirrhosis
|
3 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Asthma
|
17 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Obstructive sleep apnea
|
21 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
End stage renal disease
|
5 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Depression
|
27 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Anxiety
|
32 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Cancer
|
14 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Organ transplantation
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Results of this Aim will provide data about the prevalence of COPD in the hospitalized population with AMI in our network.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=3458 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI)
|
562 Participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Based on participants with spirometry data available in their medical records in the 3 years prior to their admission.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=14 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=83 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Forced Expiratory Volume (FEV1), L; Post-bronchodilator
|
1.6 Liters
Interval 0.7 to 2.7
|
1.7 Liters
Interval 0.5 to 3.4
|
PRIMARY outcome
Timeframe: BaselinePopulation: Based on participants with spirometry data available in their medical records in the 3 years prior to their admission.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=14 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=82 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
FEV1 % Predicted; Post-bronchodilator
|
51.5 Percent predicted
Interval 26.0 to 85.0
|
67.0 Percent predicted
Interval 24.0 to 105.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: Based on participant self report or from electronic medical records if consent not obtained.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=77 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Number of Participants With Prescriptions for Home Oxygen
|
16 Participants
|
78 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Based on participant self report or from electronic medical records if consent not obtained.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=77 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Number of Participants That Received a Course of Systemic Corticosteroids and/or Antibiotics in Past Year
|
21 Participants
|
111 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=77 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year
|
1.0 COPD exacerbation treatment courses
Interval 1.0 to 4.0
|
1.0 COPD exacerbation treatment courses
Interval 1.0 to 10.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: Based on participant self report or from electronic medical records if consent not obtained.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=77 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Respiratory Episodes Requiring Care in the Emergency Department in Past Year
|
11 episodes
|
69 episodes
|
PRIMARY outcome
Timeframe: BaselinePopulation: Based on participant self report or from electronic medical records if consent not obtained.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=77 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Respiratory Episodes Leading to Hospitalization in Past Year
|
10 episodes
|
56 episodes
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=77 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Number of Hospitalizations in Past Year
|
1.0 number of hospitalizations
Interval 1.0 to 4.0
|
1.0 number of hospitalizations
Interval 1.0 to 15.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: Based on participant self report or from electronic medical records if consent not obtained.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=77 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=502 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Respiratory Episodes Requiring Intubation in Past Year
|
0 episodes
|
4 episodes
|
PRIMARY outcome
Timeframe: 6 month follow-upPopulation: Based on participant self report if consent obtained and from electronic medical records.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=73 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=480 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Time to Death, or First Hospitalization or Revascularization Event
|
19 days
Interval 6.0 to 64.0
|
37.5 days
Interval 14.0 to 84.25
|
PRIMARY outcome
Timeframe: 6 month follow-upPopulation: Based on participant self report if consent obtained and from electronic medical records.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=73 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=480 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Risk of Death, Hospitalization or Revascularization Event
|
35 Participants
|
195 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Based on participant self report if consent obtained and from electronic medical records.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=73 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=480 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
|
23.5 days
Interval 9.75 to 97.5
|
37.5 days
Interval 13.0 to 97.25
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Based on participant self report if consent obtained and from electronic medical records.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=73 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=480 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
|
20 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Based on participant self report if consent obtained and from electronic medical records.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=73 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=480 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Time to Respiratory/COPD-related Death or Hospitalization Event
|
93 dats
Interval 17.75 to 114.37
|
61 dats
Interval 37.0 to 118.0
|
SECONDARY outcome
Timeframe: 6 month follow-upPopulation: Based on participant self report if consent obtained and from electronic medical records.
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.
Outcome measures
| Measure |
Patients Who Underwent Cardiac Catheterization for AMI
n=73 Participants
Patients screened who underwent cardiac catheterization for AMI
|
Discharged With Beta Blockers
n=480 Participants
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Risk of Respiratory/COPD-related Death or Hospitalization Event
|
10 Participants
|
45 Participants
|
Adverse Events
Not Discharged With Beta Blockers
Discharged With Beta Blockers
Serious adverse events
| Measure |
Not Discharged With Beta Blockers
n=73 participants at risk
Participants discharged without a beta blocker prescription
|
Discharged With Beta Blockers
n=480 participants at risk
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
General disorders
Nonfatal overall hospitalization or revascularization
|
39.7%
29/73 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
34.0%
163/480 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
|
Cardiac disorders
Nonfatal CVD hospitalization or revascularization
|
23.3%
17/73 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
21.9%
105/480 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
|
Respiratory, thoracic and mediastinal disorders
Nonfatal COPD or respiratory hospitalization
|
12.3%
9/73 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
7.7%
37/480 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
Other adverse events
| Measure |
Not Discharged With Beta Blockers
n=73 participants at risk
Participants discharged without a beta blocker prescription
|
Discharged With Beta Blockers
n=480 participants at risk
Participants discharged with a beta blocker prescription
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Antibiotics or steroids for COPD exacerbation
|
19.2%
14/73 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
17.1%
82/480 • 6-month followup
Serious Adverse events were classified as any hospitalization after the primary event, or any revascularization. Non-serious adverse events were classified as use of steroids or antibiotics for a respiratory condition or COPD exacerbation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place