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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Observational |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | 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. | 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. | 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. | Baseline |
| Number of Courses of Systemic Corticosteroids and/or Antibiotics in Past Year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects hospitalized and who undergo cardiac catheterization with AMI and have EMR-documented COPD.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Dransfield, MD | University of Alabama at Birmingham | Principal Investigator |
| John Connett, PhD | University of Minnesota | Principal Investigator |
| Stephen Lazarus, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California, San Francisco-Fresno |
This is an observational study. Participants that were discharged alive were categorized based on whether they had a beta blocker prescription at discharge.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Not Discharged With Beta Blockers | Participants discharged without a beta blocker prescription |
| FG001 | Discharged With Beta Blockers | Participants discharged with a beta blocker prescription |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 |
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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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 6 month follow-up |
| 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. | 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. | 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. | 6 month follow-up |
| Fresno |
| California |
| 93701 |
| United States |
| LA BioMed at Harbor-UCLA Medical Center | Los Angeles | California | 90502 | United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| National Jewish Medical & Research Center | Denver | Colorado | 80206 | United States |
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Louisiana State University | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Veteran's Administration Medical Center | Minneapolis | Minnesota | 55417 | United States |
| HealthPartners Research Foundation | Minneapolis | Minnesota | 55440 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| New York Presbyterian/Queens | Flushing | New York | 11355 | United States |
| Columbia University | New York | New York | 10027 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Temple University Lung Center | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132-4701 | United States |
| The University of Vermont | Burlington | Vermont | 05405 | United States |
| University of Washington School of Medicine | Spokane | Washington | 99258 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Patients with COPD who underwent cardiac catheterization for AMI categorized by whether they were discharged with or without a prescription for any beta-blocker.
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Discharged With Beta Blockers | Participants discharged without a beta blocker prescription |
| BG001 | Discharged With Beta Blockers | Participants discharged with a beta blocker prescription |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| BMI | Median | Full Range | kg/m^2 |
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| Smoking status | Count of Participants | Participants |
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| High blood pressure | Count of Participants | Participants |
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| Hyperlipidemia | Count of Participants | Participants |
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| Coronary artery disease | Count of Participants | Participants |
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| Heart attack | Count of Participants | Participants |
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| Heart failure | Count of Participants | Participants |
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| Percutaneous coronary intervention | Count of Participants | Participants |
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| Coronary artery bypass grafting | Count of Participants | Participants |
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| Peripheral vascular disease | Count of Participants | Participants |
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| Stroke | Count of Participants | Participants |
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| Diabetes mellitus | Count of Participants | Participants |
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| Cirrhosis | Count of Participants | Participants |
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| Asthma | Count of Participants | Participants |
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| Obstructive sleep apnea | Count of Participants | Participants |
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| End stage renal disease | Count of Participants | Participants |
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| Depression | Count of Participants | Participants |
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| Anxiety | Count of Participants | Participants |
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| Cancer | Count of Participants | Participants |
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| Organ transplantation | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline |
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| 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. | Based on participants with spirometry data available in their medical records in the 3 years prior to their admission. | Posted | Median | Full Range | Liters | Baseline |
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| 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. | Based on participants with spirometry data available in their medical records in the 3 years prior to their admission. | Posted | Median | Full Range | Percent predicted | Baseline |
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| 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. | Based on participant self report or from electronic medical records if consent not obtained. | Posted | Count of Participants | Participants | Baseline |
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| 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. | Based on participant self report or from electronic medical records if consent not obtained. | Posted | Count of Participants | Participants | Baseline |
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| 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. | 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. | Posted | Median | Full Range | COPD exacerbation treatment courses | Baseline |
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| 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. | Based on participant self report or from electronic medical records if consent not obtained. | Posted | Number | episodes | Baseline |
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| 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. | Based on participant self report or from electronic medical records if consent not obtained. | Posted | Number | episodes | Baseline |
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| 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. | 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. | Posted | Median | Full Range | number of hospitalizations | Baseline |
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| 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. | Based on participant self report or from electronic medical records if consent not obtained. | Posted | Number | episodes | Baseline |
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| 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. | Based on participant self report if consent obtained and from electronic medical records. | Posted | Median | Inter-Quartile Range | days | 6 month follow-up |
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| 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. | Based on participant self report if consent obtained and from electronic medical records. | Posted | Count of Participants | Participants | 6 month follow-up |
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| 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. | Based on participant self report if consent obtained and from electronic medical records. | Posted | Median | Inter-Quartile Range | days | 6 month follow-up |
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| 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. | Based on participant self report if consent obtained and from electronic medical records. | Posted | Count of Participants | Participants | 6 month follow-up |
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| 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. | Based on participant self report if consent obtained and from electronic medical records. | Posted | Median | Inter-Quartile Range | dats | 6 month follow-up |
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| 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. | Based on participant self report if consent obtained and from electronic medical records. | Posted | Count of Participants | Participants | 6 month follow-up |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Not Discharged With Beta Blockers | Participants discharged without a beta blocker prescription | 11 | 73 | 29 | 73 | 14 | 73 |
| EG001 | Discharged With Beta Blockers | Participants discharged with a beta blocker prescription | 48 | 480 | 163 | 480 | 82 | 480 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nonfatal overall hospitalization or revascularization | General disorders | ICD-10 | Systematic Assessment |
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| Nonfatal CVD hospitalization or revascularization | Cardiac disorders | ICD-10 | Systematic Assessment |
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| Nonfatal COPD or respiratory hospitalization | Respiratory, thoracic and mediastinal disorders | ICD-10 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Antibiotics or steroids for COPD exacerbation | Respiratory, thoracic and mediastinal disorders | ICD-10 | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Dransfield | UAB Lung Health Center | 205-934-5425 | mdransfield@uabmc.edu |
| Oct 8, 2024 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Other |
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| Unknown |
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| Former smoker |
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| Never smoker |
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