An Observational Study of Beta-Blocker Use in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 584
- 试验地点
- 24
- 主要终点
- Respiratory Episodes Requiring Intubation in Past Year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Respiratory Episodes Requiring Intubation in Past Year
时间窗: 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
时间窗: 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
时间窗: 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.
Prevalence of COPD in Patients Admitted to the Hospital With an Acute Myocardial Infarction (AMI)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Time to Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event(6 month follow-up)
- Risk of Cardiovascular Disease (CVD) Related Death or First CVD-related Hospitalization/Revascularization Event(6 month follow-up)
- Time to Respiratory/COPD-related Death or Hospitalization Event(6 month follow-up)
- Risk of Respiratory/COPD-related Death or Hospitalization Event(6 month follow-up)