Coronary Artery Disease
Conditions
Keywords
coronary artery disease, enhanced external counterpulsation
Brief summary
To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.
Interventions
Treatment of enhanced external counterpulsation (EECP) with a prespecified protocol on top of a guideline-driven standard medical therapy. EECP Protocol is defined as a standard session of a total of 36 hours of EECP treatment, given one hour per day, six days per week. The same session is thereafter repeated at least once every year.
DRUGGuideline-driven standard medical therapy
Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* at least one coronary lesion of more than 50% stenosis shown by angiography * history of acute myocardial infarction(at least one month before) * history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting) * typical angina episodes with evidence of myocardial ischemia * 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, bleeding disorders or identified bleeding tendency; * Lower limb infection, phlebitis, varicosity, deep venous thrombosis; * Progressive malignancies or diseases with poor prognosis; * uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction | up to 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiac structure and exercise tolerance | up to 5 years | cardiac chamber diameter, left ventricular wall thickness, ejection fraction, and etc., as deternmined by echocardiographic examination; exercise tolerance, as determined by Treadmill's Test |
| new-onset diabetes | up to 5 years | fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c) |
| atherosclerosis | up to 5 years | peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP & DBP) |
| 24-hour urinary protein | up to 5 years | 24-hour urinary protein/albumin by urinalysis |
| vascular endothelial function | up to 5 years | measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD) |
| revascularization rate | up to 5 years | — |
| rehospitalization rate | up to 5 years | — |
| rate of acute myocardial infarction | up to 5 years | — |
| all-cause mortality | up to 5 years | — |
Countries
China
Contacts
Primary ContactYan Zhang, M.D.
Backup ContactQiang Xie, M.D.
Outcome results
None listed