Coronary Artery Disease Clinical Trial
— ECP-CADOfficial title:
Effect of External Counter Pulsation on Coronary Artery Disease (ECP-CAD)
Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of citizens, external counter pulsation (ECP) has been elucidated that it may release angina symptoms and improve the prognosis of CAD, however, no multi-center control clinical study has been reported for further recommendation. The aim of this study is to evaluate the effect of ECP on CAD. To address this assumption, investigators enroll participants with stable CAD and randomize them into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks, and the follow-up will last for 1 year. The primary endpoint is the 1-year composite cardiovascular events (CCE), secondary endpoints include frequency of angina pectoris, heart function, biomarkers of arteriosclerosis, exercise tolerance and endothelial function.
Status | Recruiting |
Enrollment | 380 |
Est. completion date | June 30, 2019 |
Est. primary completion date | May 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of coronary artery disease; - Signed informed consent. Exclusion Criteria: - Obvious aortic insufficiency; - Aortic aneurysm; - Aortic dissection; - Coronary fistula or severe coronary aneurysm; - Symptomatic Congestive heart failure; - Valvular heart disease; - Congenital heart diseases; - Cardiomyopathies - Cerebral hemorrhage within six months; - Uncontrolled hypertension, defined as SBP=180mmHg or DBP=110mmHg; - Lower limb infection; - Deep venous thrombosis; - Progressive malignancies |
Country | Name | City | State |
---|---|---|---|
China | Xiangya Hospital Central South University | Changsha | Hunan |
China | Tenth People's Hospital of Tongji University | Shang Hai | Shanghai |
China | The Second Affiliated Hospital of Xi'an Jiaotong University, | Xi'an | Shanxi |
China | The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Eighth Affiliated Hospital, Sun Yat-sen University | Second Affiliated Hospital of Xi'an Jiaotong University, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Zhengzhou University, Xiangya Hospital of Central South University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite cardiovascular events (CCE) | Sudden cardiac death, angina pectoris after infarction, recurrent myocardial infarction;rehospitalization rate | Change from Baseline at 1-year | |
Secondary | Frequency of angina pectoris per week | Frequency of angina pectoris | Change from Baseline frequency at 1 year | |
Secondary | Dosage of Nitroglycerin use per week | total dosage of nitroglycerin | Change from Baseline frequency and dosage at 1 year | |
Secondary | 6-minute walking distance | 6-minute walking distance | Change from Baseline distance at 1 year |
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