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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,050
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.
Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
The 1st Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe 2nd Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe 3rd Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
Time frame: up to 5 years
vascular endothelial function
measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
Time frame: up to 5 years
cardiac structure and exercise tolerance
cardiac chamber diameter, left ventricular wall thickness, ejection fraction, and etc., as deternmined by echocardiographic examination; exercise tolerance, as determined by Treadmill's Test
Time frame: up to 5 years
new-onset diabetes
fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
Time frame: up to 5 years
atherosclerosis
peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP \& DBP)
Time frame: up to 5 years
24-hour urinary protein
24-hour urinary protein/albumin by urinalysis
Time frame: up to 5 years
all-cause mortality
Time frame: up to 5 years
revascularization rate
Time frame: up to 5 years
rehospitalization rate
Time frame: up to 5 years
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The 5th Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
RECRUITINGrate of acute myocardial infarction
Time frame: up to 5 years