Cardiovascular Diseases
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALGuideline education and implementation intervention
The intervention is implemented at the investigator level and the patient level, consisted of 3 parts： 1. Disease education * Investigator level:All investigators will receive COPD and CVD disease education according to Chinese Guideline pproximately 4 weeks before the first subject is enrolled. * Patient level:After the subjects are enrolled, the cardiologists and pulmonologist will provide disease education on their respective disease areas,education will be provided every 4 weeks until the end of the study. 2. Treatment:Cardiologists and pulmonologists will work together to provide treatment management for subjects with CVD and COPD. 3. Follow-up management:the subjects will be followed up every 4 weeks.
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Give signed written informed consent to participate. 2. At least 40 years of age at baseline visit. 3. 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 ) 4. 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. 5. Subjects have the cognitive ability to conduct questionnaires after e valuated by investigators.
Exclusion criteria
1. 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. 2. 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. 3. Participant who are not able to provide written informed consent. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number and percentage of COPD in participants with CVD,CHD,AF,CHF. | Baseline | To describe the prevalence of COPD in participants with CVD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The hospitalization/readmission rate in participants with COPD. | Baseline-week12 | To describe the hospitalization/readmission rate in participants with COPD during the implementation of cardiopulmonary co-management. |
| The hospitalization/readmission rate in CHD, AF and CHF participants with COPD. | Baseline-week12 | To describe the hospitalization/readmission rate in participants with CVD during the implementation of cardiopulmonary co-management. |
| Change from baseline in SAQ score in participants with CHD and COPD. | Baseline,week4,week8,week12 | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. |
| Change from baseline in AFEQT score in participants with AF and COPD. | Baseline,week4,week8,week12 | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. |
| Change from baseline in KCCQ score in participants with CHF and COPD. | Baseline,week4,week8,week12 | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. |
| Change from baseline in CAT score in participants with COPD. | Baseline,week4,week8,week12 | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. |
| Change from baseline in SGRQ score in participants with COPD. | Baseline,week4,week8,week12 | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. |
| Change from baseline in 6MWD score in participants with COPD. | Baseline,week4,week8,week12 | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. |
| Change from baseline in pre-dose FEV1 and FVC value | Baseline,week12 | To describe the effects of cardiopulmonary co-management on lung function in participants with COPD. |
| Change from baseline in FEV1 and FVC value within 4 hours post-dosing. | Baseline,week12 | To describe the effects of cardiopulmonary co-management on lung function in participants with COPD. |
| The rate of AF recurrence in participants with AF and COPD. | Baseline-week12 | To describe the rate of AF recurrence during the period of cardiopulmonary co-management. |
| Change from baseline in BNP/NT-proBNP value in the participants with CHF and COPD. | Baseline,week12 | To describe the change of biomarkers in the participants with CVD and COPD during the period of cardiopulmonary co-management. |
| Change from baseline in blood lipids value(TC, LDL, HDL and TG) in the participants with CHD and COPD. | Baseline,week12 | To describe the change of biomarkers in the participants with CVD and COPD during the period of cardiopulmonary co-management. |
| Propotion of newly diagnosed COPD participants in subjects with COPD at baseline. | Baseline | To describe the undiagnosed rate of COPD in participants with CVD. |
| Propotion of newly diagnosed COPD patients in CHD, AF and CHF participants with COPD at baseline. | Baseline | To describe the undiagnosed rate of COPD in participants with CVD. |
| Propotion of participants at high risk of COPD in participants with CVD, CHD, AF and CHF at baseline. | Baseline | To describe the proportion of participants at high risk of COPD among CVD patients. |
| 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 | To describe the COPD-related treatment patterns before and after the implementation of cardiopulmonary co-management. |
| Propotion of participants at high risk of COPD diagnosed with COPD in participants with CVD, CHD, AF and CHF at baseline. | Baseline | To describe the proportion of participants at high risk of COPD among CVD patients. |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed