Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Difference in the proportion of diastolic dysfunction in pauci-inflammatory exacerbations vs. inflammatory exacerbations
研究概览
简要总结
This is a prospective study to determine the relationships between pauci-inflammatory exacerbations and diastolic dysfunction, and their implications in hospitalized patients with acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a number of comparisons will be made in subjects enrolled during acute exacerbation with similar measurements made in the stable phase after recovery from exacerbation after at least 35 days from index hospitalization or prior exacerbation.
详细描述
Informed consent will be obtained within the first 24 hours of admission. Written informed consent will be obtained from the subject or a legally authorized representative.
Visit Schedule:
V1 (Day 0 of Hospitalization):
Demographic and clinical information including age, gender, race, smoking status, number of pack-years of smoking, body mass index, waist hip circumference, co-morbidities such as diabetes mellitus, hypertension, hyperlipidemia, depression, coronary artery disease and chronic kidney disease, history of previous exacerbations, detailed occupation history, and detailed medication history with emphasis on cardiovascular medications will be conducted. The COPD Assessment Test (CAT) questionnaire and the modified Medical Research Council (mMRC) assessment will be administered. Bed-side spirometry will be conducted. Blood will be drawn for lab tests (about 30 mL or 6 teaspoons). Electrocardiography (ECG), lung ultrasound and echocardiography will be performed.
V2 (hospital discharge day or day 3 of hospitalization whichever is earlier):
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 and older
- •Patients admitted to the general medicine or pulmonary floors, or the medical intensive care unit with a primary diagnosis of acute exacerbation of COPD will be eligible for the study.
排除标准
- •Patients with a secondary diagnosis of congestive heart failure and other respiratory conditions that the investigator's deem could confound the diagnosis including but not limited to pneumonia, bronchiectasis and lung cancer will be excluded.
- •Pregnant or breastfeeding women will be excluded.
- •Patients with conditions that preclude an adequate echocardiogram such as hemodynamically significant arrhythmias will also be excluded.
结局指标
主要结局
Difference in the proportion of diastolic dysfunction in pauci-inflammatory exacerbations vs. inflammatory exacerbations
时间窗: at baseline (at time of hospitalization)
We will estimate the frequency of diastolic dysfunction on echocardiogram in exacerbations that are pauci-inflammatory vs. inflammatory at the time of enrollment.
次要结局
- Rate of exacerbations(1 year post hospitalization)
- Differences in COPD Assessment Test (CAT) in those with and without diastolic dysfunction(at or after 35 days post hospitalization)
- Differences in 6-minute walk distance(at or after 35 days post hospitalization.)
- Differences in dyspnea using the modified Medical Research Council (mMRC) scale(at or after 35 days post hospitalization)
- Differences in dyspnea using the San Diego Shortness of Breath Questionnaire (SOBQ)(at or after 35 days post hospitalization)
研究者
Surya P Bhatt
Principal Investigator
University of Alabama at Birmingham