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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guideline education and implementation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guideline education and implementation intervention | Behavioral | The intervention is implemented at the investigator level and the patient level, consisted of 3 parts:
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and percentage of COPD in participants with CVD,CHD,AF,CHF. | To describe the prevalence of COPD in participants with CVD. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The hospitalization/readmission rate in participants with COPD. | To describe the hospitalization/readmission rate in participants with COPD during the implementation of cardiopulmonary co-management. | Baseline-week12 |
| The hospitalization/readmission rate in CHD, AF and CHF participants with COPD. |
| Measure | Description | Time Frame |
|---|---|---|
| The exacerbation rate in CVD, CHD, AF and CHF participants with COPD over 12 weeks. | To explore the exacerbation rate in participants with CVD and COPD during the period of cardiopulmonary co-management. | Baseline-week12 |
| Rate of MACE in CVD, CHD, AF and CHF participants with COPD over 12 weeks. |
Inclusion Criteria:
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,
Participants can undergo spirometry testing and does not have the following serious diseases or disease states:
Subjects have the cognitive ability to conduct questionnaires after e valuated by investigators.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Anqing | 246004 | China | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. 'Yes' , indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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|
To describe the hospitalization/readmission rate in participants with CVD during the implementation of cardiopulmonary co-management. |
| Baseline-week12 |
| Change from baseline in SAQ score in participants with CHD and COPD. | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. | Baseline,week4,week8,week12 |
| Change from baseline in AFEQT score in participants with AF and COPD. | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. | Baseline,week4,week8,week12 |
| Change from baseline in KCCQ score in participants with CHF and COPD. | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. | Baseline,week4,week8,week12 |
| Change from baseline in CAT score in participants with COPD. | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. | Baseline,week4,week8,week12 |
| Change from baseline in SGRQ score in participants with COPD. | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. | Baseline,week4,week8,week12 |
| Change from baseline in 6MWD score in participants with COPD. | To describe the effects of cardiopulmonary co-management on quality of life, symptoms and activity tolerance in participants with COPD. | Baseline,week4,week8,week12 |
| Change from baseline in pre-dose FEV1 and FVC value | To describe the effects of cardiopulmonary co-management on lung function in participants with COPD. | Baseline,week12 |
| Change from baseline in FEV1 and FVC value within 4 hours post-dosing. | To describe the effects of cardiopulmonary co-management on lung function in participants with COPD. | Baseline,week12 |
| The rate of AF recurrence in participants with AF and COPD. | To describe the rate of AF recurrence during the period of cardiopulmonary co-management. | Baseline-week12 |
| Change from baseline in BNP/NT-proBNP value in the participants with CHF and COPD. | To describe the change of biomarkers in the participants with CVD and COPD during the period of cardiopulmonary co-management. | Baseline,week12 |
| Change from baseline in blood lipids value(TC, LDL, HDL and TG) in the participants with CHD and COPD. | To describe the change of biomarkers in the participants with CVD and COPD during the period of cardiopulmonary co-management. | Baseline,week12 |
| Propotion of newly diagnosed COPD participants in subjects with COPD at baseline. | To describe the undiagnosed rate of COPD in participants with CVD. | Baseline |
| Propotion of newly diagnosed COPD patients in CHD, AF and CHF participants with COPD at baseline. | To describe the undiagnosed rate of COPD in participants with CVD. | Baseline |
| Propotion of participants at high risk of COPD in participants with CVD, CHD, AF and CHF at baseline. | To describe the proportion of participants at high risk of COPD among CVD patients. | Baseline |
| Propotion of participants at high risk of COPD diagnosed with COPD in participants with CVD, CHD, AF and CHF at baseline. | To describe the proportion of participants at high risk of COPD among CVD patients. | Baseline |
| 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. | To describe the COPD-related treatment patterns before and after the implementation of cardiopulmonary co-management. | Baseline,week12 |
To explore the occurrence of MACE event in participants with CVD and COPD during the period of cardiopulmonary co-management. |
| Baseline-week12 |
| Rate of differente types of MACE in CVD, CHD, AF and CHF participants with COPD over 12 weeks. | To explore the occurrence of MACE event in participants with CVD and COPD during the period of cardiopulmonary co-management. | Baseline-week12 |
| Risk factors for COPD diagnosis in CHD, AF and CHF participants (analysis scope includes demographics, physiological data, family history, smoking status, age, comorbidities, lung function parameters, biomarkers, etc.) | To explore the risk factors in CVD participants with COPD. | Baseline |
| Risk factors for MACE in participants with CVD and COPD (analysis scope includes baseline characteristics, baseline PROs, drug treatment, non-drug treatment, lung function parameters, biomarkers, etc.) | To explore the risk factors of MACE in participants with CVD and COPD. | Baseline |
| Change(Mean, standard deviation, median, interquartile range, minimum, and maximum values) from baseline in pre-dose and post-dose IOS parameters(Z at 5 Hz [kPa/(L/s)]、R at 5 Hz [kPa/(L/s)]、R at 10 Hz [kPa/(L/s)] and so on) at week 12. | To explore the changes in IOS parameters in participants with COPD during the period of cardiopulmonary co-management. | Baseline,week12 |
| Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre-dose/post-dose IOS parameters and change from baseline in CAT score at week 12. | To explore the correlation between changes in IOS parameters and symptoms in COPD participants. | Baseline,week12 |
| Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre-dose/post-dose IOS parameters and change from baseline in mMRC score at week 12. | To explore the correlation between changes in IOS parameters and symptoms in COPD participants. | Baseline,week12 |
| Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre/post-dose spirometry parameters and change from baseline in CAT score at week 12. | To explore the correlation between changes in spirometry parametersH and symptoms in COPD participants. | Baseline,week12 |
| Correlation(via Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between change from baseline in pre/post-dose spirometry parameters and change from baseline in mMRC score at week 12. | To explore the correlation between changes in spirometry parametersH and symptoms in COPD participants. | Baseline,week12 |
| Area Under Curve(AUC) of oscillometry parameters for identifying COPD, along with sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) at the optimal cut-off point. | To analyse the diagnostic performance of oscillometry in CVD with COPD | Baseline |
| Correlation(via Pearson/Spearman's rank correlation coefficient(-1 to 1), -1=negative correlation,0=no correlation, +1=positive correlation) between oscillometry parameters and spirometry parameters. | To explore the correlation between oscillometry parameters and spirometry parameters in all participants. | Baseline,week12 |
| Recruiting |
| Beijing |
| 100029 |
| China |
| Research Site | Not yet recruiting | Beijing | 100029 | China |
| Research Site | Not yet recruiting | Beijing | 100037 | China |
| Research Site | Not yet recruiting | Beijing | 100050 | China |
| Research Site | Recruiting | Beijing | 100191 | China |
| Research Site | Not yet recruiting | Changsha | 410005 | China |
| Research Site | Recruiting | Changsha | 410300 | China |
| Research Site | Not yet recruiting | Chaohu | 238001 | China |
| Research Site | Not yet recruiting | Chengdu | 610021 | China |
| Research Site | Not yet recruiting | Chengdu | 610041 | China |
| Research Site | Recruiting | Chengdu | 610072 | China |
| Research Site | Recruiting | Chifeng | 024206 | China |
| Research Site | Recruiting | Chongqing | 400010 | China |
| Research Site | Not yet recruiting | Dalian | 116001 | China |
| Research Site | Not yet recruiting | Dingzhou | 562100 | China |
| Research Site | Not yet recruiting | Dongguan | 523009 | China |
| Research Site | Not yet recruiting | Foshan | CN-528000 | China |
| Research Site | Recruiting | Fuyang | 236400 | China |
| Research Site | Not yet recruiting | Fuzhou | 350005 | China |
| Research Site | Not yet recruiting | Ganzhou | 341699 | China |
| Research Site | Not yet recruiting | Guanghan | 618300 | China |
| Research Site | Not yet recruiting | Guangzhou | 510080 | China |
| Research Site | Not yet recruiting | Guangzhou | 510100 | China |
| Research Site | Recruiting | Guangzhou | 510280 | China |
| Research Site | Not yet recruiting | Guangzhou | 510515 | China |
| Research Site | Recruiting | Haikou | 570311 | China |
| Research Site | Not yet recruiting | Hangzhou | 310016 | China |
| Research Site | Recruiting | Hangzhou | 310030 | China |
| Research Site | Recruiting | Harbin | 150001 | China |
| Research Site | Recruiting | Harbin | 150036 | China |
| Research Site | Not yet recruiting | Hefei | 230001 | China |
| Research Site | Recruiting | Hefei | 230011 | China |
| Research Site | Recruiting | Hubei | 434300 | China |
| Research Site | Recruiting | Jinhua | 321099 | China |
| Research Site | Not yet recruiting | Jinzhong | 030600 | China |
| Research Site | Recruiting | Jiujiang | 332000 | China |
| Research Site | Not yet recruiting | Kaiyuan | 661600 | China |
| Research Site | Not yet recruiting | Kunming | 650032 | China |
| Research Site | Not yet recruiting | Kunming | 650101 | China |
| Research Site | Recruiting | Lanzhou | 730000 | China |
| Research Site | Not yet recruiting | Leping | 333300 | China |
| Research Site | Not yet recruiting | Lianjiang | 524400 | China |
| Research Site | Recruiting | Linhai | 317000 | China |
| Research Site | Recruiting | Meizhou | 514031 | China |
| Research Site | Not yet recruiting | Mianyang | 621000 | China |
| Research Site | Recruiting | Nanchang | 330006 | China |
| Research Site | Not yet recruiting | Neijiang | 641200 | China |
| Research Site | Recruiting | Ningbo | 315600 | China |
| Research Site | Not yet recruiting | Ningbo | 315700 | China |
| Research Site | Recruiting | Putian | 351106 | China |
| Research Site | Not yet recruiting | Quanzhou | 362000 | China |
| Research Site | Recruiting | Shanghai | 200072 | China |
| Research Site | Not yet recruiting | Shanghai | 200080 | China |
| Research Site | Recruiting | Shanghai | 201114 | China |
| Research Site | Not yet recruiting | Shanghai | 201199 | China |
| Research Site | Recruiting | Shanghai | 201318 | China |
| Research Site | Not yet recruiting | Shantou | 515031 | China |
| Research Site | Not yet recruiting | Shantou | 515041 | China |
| Research Site | Not yet recruiting | Shenyang | 110004 | China |
| Research Site | Not yet recruiting | Shenzhen | 518036 | China |
| Research Site | Recruiting | Shijiazhuang | 50051 | China |
| Research Site | Not yet recruiting | Sichuan | 643200 | China |
| Research Site | Recruiting | Suining | 629000 | China |
| Research Site | Recruiting | Suzhou | 215300 | China |
| Research Site | Recruiting | Taiyuan | 030001 | China |
| Research Site | Not yet recruiting | Taiyuan | 030032 | China |
| Research Site | Recruiting | Tai’an | 271000 | China |
| Research Site | Not yet recruiting | Tianjin | 300050 | China |
| Research Site | Recruiting | Tianjin | 300211 | China |
| Research Site | Not yet recruiting | Tianjin | 300222 | China |
| Research Site | Not yet recruiting | Tianmen | 431700 | China |
| Research Site | Recruiting | Wuhan | 430000 | China |
| Research Site | Not yet recruiting | Wuhan | 430000 | China |
| Research Site | Not yet recruiting | Wuxi | 214122 | China |
| Research Site | Not yet recruiting | Xi'an | 710100 | China |
| Research Site | Recruiting | Xiamen | 361003 | China |
| Research Site | Recruiting | Xiangyang | 441000 | China |
| Research Site | Recruiting | Xinzheng | 451100 | China |
| Research Site | Recruiting | Xuzhou | 221009 | China |
| Research Site | Recruiting | Yangzhou | 225001 | China |
| Research Site | Recruiting | Yulin | 537000 | China |
| Research Site | Recruiting | Zhangzhou | 363099 | China |
| Research Site | Not yet recruiting | Zhengzhou | 450000 | China |
| Research Site | Recruiting | Zunyi | 563100 | China |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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