NCT06909773招募中不适用
The Prevalence of COPD in Patients With Cardiovascular Disease and the Benefit of Cardiopulmonary Co-management -A Multi-center, Prospective, Interventional Study (PRECEDE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 3,000
- 试验地点
- 85
- 主要终点
- The number and percentage of COPD in participants with CVD,CHD,AF,CHF.
研究概览
简要总结
This is a multi-center, prospective, and interventional study conducted in 3 types of cardiovascular diseases (CVD) participants , including 3 cohorts which are patients with newly or previously diagnosed coronary heart disease ( CHD), atrial fibrillation ( AF) and chronic heart failure (CHF).
详细描述
The mainly purpose of this study is describe the prevalence of COPD of the participants with 3 types of CVD who are aged 40 years or older, and also observe the effect of cardiopulmonary co management on the short term prognosis of participants with CVD and COPD.
This study will enroll approximately 3,000 participants, with approximately 1,000 participants in each cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give signed written informed consent to participate.
- •At least 40 years of age at baseline visit.
- •Previous or newly diagnosed by at least one of the 3 types of CVD which are,
- •Coronary heart disease ( CHD )
- •Atrial fibrillation (AF )
- •Chronic heart failure ( CHF )
- •Participants can undergo spirometry testing and does not have the following serious diseases or disease states：
- •Shock within the last 3 months
- •Mycardial infarction, stroke or unstable angina within last 1 month
- •Currently suffering from severe HF or severe arrhythmia. Severe HF refers to the need for intravenous administration of vasoactive drugs and diuretics; severe arrhythmia refers to arrhythmias that cause hemodynamic instability, such as ventricular fibrillation and ventricular tachycardia
- •Severe hemoptysis or active gastrointestinal bleeding within last 1 month
- •Patients with seizures requiring medication
- •Patients with hypertensive crisis or uncontrolled hypertension [systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg (1 mmHg = 0.133 kPa)]
- •Patients with active respiratory infectious diseases or infectious diseases, such as open pulmonary tuberculosis, influenza, new coronavirus infection, and acute pneumonia
- •Patients with aortic or cerebral aneurysms
- •Pneumothorax and pneumothorax healing within last 1 month
- •Patients with severe hyperthyroidism
- •Patients who have recently had eye, ear, cranial or thoracic or abdominal surgery Note: If the patient can cooperate by completing a single, effective forced exhalation (≥6 seconds), then spirometry testing can be performed.
- •Subjects have the cognitive ability to conduct questionnaires after e valuated by investigators.
排除标准
- •Significant diseases or conditions, which, in the opinion of the investigator, may put the participant at risk because of participation in the study or may influence either the results of the study or the participant's ability to participate in the study.
- •Women who are pregnant or lactating or are planning to become pregnant, or women of childbearing potential who are not using an acceptable method of contraception.
- •Participant who are not able to provide written informed consent.
- •Treatment with investigational study drug or device in another clinical study within the last 30 days or five half lives prior to baseline visit , whichever is longer.
研究组 & 干预措施
Guideline education and implementation
Other
干预措施: Guideline education and implementation intervention (Behavioral)
结局指标
主要结局
The number and percentage of COPD in participants with CVD,CHD,AF,CHF.
时间窗: Baseline
To describe the prevalence of COPD in participants with CVD.
次要结局
- Change from baseline in pre-dose FEV1 and FVC value(Baseline,week12)
- Change from baseline in FEV1 and FVC value within 4 hours post-dosing.(Baseline,week12)
- Distribution of stable COPD medications by drug class (ICS, ICS/LABA, methylxanthines,etc) and others [antibiotics, systemic corticosteroids, traditional Chinese medicine, etc]) in mono or combination at baseline and week 12.(Baseline,week12)
- The hospitalization/readmission rate in participants with COPD.(Baseline-week12)
- The hospitalization/readmission rate in CHD, AF and CHF participants with COPD.(Baseline-week12)
- Change from baseline in SAQ score in participants with CHD and COPD.(Baseline,week4,week8,week12)
- Change from baseline in AFEQT score in participants with AF and COPD.(Baseline,week4,week8,week12)
- Change from baseline in KCCQ score in participants with CHF and COPD.(Baseline,week4,week8,week12)
- Change from baseline in CAT score in participants with COPD.(Baseline,week4,week8,week12)
- Change from baseline in SGRQ score in participants with COPD.(Baseline,week4,week8,week12)
- Change from baseline in 6MWD score in participants with COPD.(Baseline,week4,week8,week12)
- The rate of AF recurrence in participants with AF and COPD.(Baseline-week12)
- Change from baseline in BNP/NT-proBNP value in the participants with CHF and COPD.(Baseline,week12)
- Change from baseline in blood lipids value(TC, LDL, HDL and TG) in the participants with CHD and COPD.(Baseline,week12)
- Propotion of newly diagnosed COPD participants in subjects with COPD at baseline.(Baseline)
- Propotion of newly diagnosed COPD patients in CHD, AF and CHF participants with COPD at baseline.(Baseline)
- Propotion of participants at high risk of COPD in participants with CVD, CHD, AF and CHF at baseline.(Baseline)
- Propotion of participants at high risk of COPD diagnosed with COPD in participants with CVD, CHD, AF and CHF at baseline.(Baseline)
研究者
研究点 (85)
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