Pulmonary Disease, Chronic ObstructiveBLOCK2NCT04717492

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Observational
How many people: 584 participants
Where: 24 sitesUnited States
Study dates: 28 Jun 2020to 2 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects hospitalized and who undergo cardiac catheterization with AMI and have EMR-documented COPD.

Who may be able to join

Willing and able to provide informed consent (applicable for Option 1 and 2 only)
Men and women age 35 or older
Admitted to hospital from the Emergency Department or by hospital to hospital transfer with a primary diagnosis of AMI
Undergo cardiac catheterization for AMI
EMR-documented COPD

Who cannot join

Cognitive disorder that in the judgment of the investigator impairs understanding of the study objectives or assessments (applicable for Option 1 only)
Vulnerable populations, including prisoners and pregnant women

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

University of Michigan
Ann Arbor, Michigan, 48109
University of Maryland Baltimore
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
The University of Vermont
Burlington, Vermont, 05405
Northwestern University
Chicago, Illinois, 60611
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
Cleveland Clinic
Cleveland, Ohio, 44195
National Jewish Medical & Research Center
Denver, Colorado, 80206
New York Presbyterian/Queens
Flushing, New York, 11355
University of California, San Francisco-Fresno
Fresno, California, 93701
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
LA BioMed at Harbor-UCLA Medical Center
Los Angeles, California, 90502
Veteran's Administration Medical Center
Minneapolis, Minnesota, 55417
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440
Louisiana State University
New Orleans, Louisiana, 70112
Columbia University
New York, New York, 10027
Weill Cornell Medicine
New York, New York, 10065
Temple University Lung Center
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132-4701
University of California at San Francisco
San Francisco, California, 94143
University of Washington School of Medicine
Spokane, Washington, 99258

Other trials in United States

About this study

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

Read the 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.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Observational
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Cardiac, Cardiovascular, Beta blockers, Acute Myocardial Infarction, Cardiac Catheterization
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ObservationalOther
Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: 6 month follow-up
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.
Measured: 6 month follow-up

Secondary outcomes (4)

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.
Measured: 6 month follow-up
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.
Measured: 6 month follow-up
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.
Measured: 6 month follow-up
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.
Measured: 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 20202 Dec 2022

First posted22 Jan 2021
Study start28 Jun 2020
Primary completion18 May 2022
Study completion2 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 584 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04717492
Sponsor's protocol ID: 1512M81981-Observational
Acronym: BLOCK2
Status last verified: Dec 2024
First submitted: 15 Jan 2021
Last updated: 31 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study of Beta-Blocker Use in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Myocardial Infarction
ClinicalTrials.gov ID: NCT04717492
Acronym / sponsor ID: BLOCK2 / 1512M81981-Observational
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Cardiac, Cardiovascular, Beta blockers, Acute Myocardial Infarction, Cardiac Catheterization
Study type: Observational
Recruitment status: Completed
Enrolment: 584 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: United States Department of Defense, University of Alabama at Birmingham
Study start: 28 Jun 2020 (actual)
Primary completion: 18 May 2022 (actual)
Study completion: 2 Dec 2022 (actual)
First posted: 22 Jan 2021 (actual)
Results: Posted 31 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aim 2. To determine the association between beta-blocker use at discharge and cardiopulmonary outcomes in patients with COPD and AMI.

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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects hospitalized and who undergo cardiac catheterization with AMI and have EMR-documented COPD.

Key inclusion criteria (5 listed)

Willing and able to provide informed consent (applicable for Option 1 and 2 only)
Men and women age 35 or older
Admitted to hospital from the Emergency Department or by hospital to hospital transfer with a primary diagnosis of AMI
Undergo cardiac catheterization for AMI
EMR-documented COPD

Key exclusion criteria (2 listed)

Cognitive disorder that in the judgment of the investigator impairs understanding of the study objectives or assessments (applicable for Option 1 only)
Vulnerable populations, including prisoners and pregnant women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ObservationalObservational	Other	–

Primary outcome

Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Leading to Hospitalization in Past Year
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Risk of Death, Hospitalization or Revascularization Event
Time frame: 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.

4 secondary outcomes

Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
Time frame: 6 month follow-up
Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event
Time frame: 6 month follow-up
Time to Respiratory/COPD-related Death or Hospitalization Event
Time frame: 6 month follow-up
Risk of Respiratory/COPD-related Death or Hospitalization Event
Time frame: 6 month follow-up

Results and safety

Results posted to the registry on 31 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Not Discharged With Beta Blockers	77	73
Discharged With Beta Blockers	502	480

Primary outcome: Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI)

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Patients Who Underwent Cardiac Catheterization for AMI n = 3458
Value	562

Population analysed: 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.

Primary outcome: Forced Expiratory Volume (FEV1), L; Post-bronchodilator

Time frame: Baseline. Median (Full Range). Unit: Liters

Measure	Not Discharged With Beta Blockers n = 14	Discharged With Beta Blockers n = 83
Value	1.6 (0.7 to 2.7)	1.7 (0.5 to 3.4)

Population analysed: Based on participants with spirometry data available in their medical records in the 3 years prior to their admission.

Primary outcome: FEV1 % Predicted; Post-bronchodilator

Time frame: Baseline. Median (Full Range). Unit: Percent predicted

Measure	Not Discharged With Beta Blockers n = 14	Discharged With Beta Blockers n = 82
Value	51.5 (26.0 to 85.0)	67.0 (24.0 to 105.0)

Population analysed: Based on participants with spirometry data available in their medical records in the 3 years prior to their admission.

Primary outcome: Number of Participants With Prescriptions for Home Oxygen

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Not Discharged With Beta Blockers n = 77	Discharged With Beta Blockers n = 502
Value	16	78

Population analysed: Based on participant self report or from electronic medical records if consent not obtained.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6-month followup. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Not Discharged With Beta Blockers	29 of 73 (39.7%)	14 of 73 (19.2%)	11 of 73
Discharged With Beta Blockers	163 of 480 (34%)	82 of 480 (17.1%)	48 of 480

Limitations and caveats (from the sponsor): Relatively small number of patients who were discharged without beta-blockers, which likely limited the power of our study to detect modest differences in outcomes. Only patients who underwent cardiac catheterization were included. Subsequent hospitalization events at facilities outside the BLOCK-COPD network may not have been captured if study staff were not notified of the event.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Dransfield, MD principal investigator

University of Alabama at Birmingham

John Connett, PhD principal investigator

University of Minnesota

Stephen Lazarus, MD principal investigator

University of California, San Francisco

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04717492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.