Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: Enhanced external counterpulsation; Drug: Guideline-driven standard medical therapy

• Registration Number: NCT01198405
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-01
• Study Start: 2008-09
• Study First Submitted: 2010-07-29
• Primary Completion: 2010-09
• Study First Submitted QC: 2010-09-09
• Last Update Submitted: 2010-09-09
• Study First Posted: 2010-09-10
• Last Update Posted: 2010-09-10
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced External Counterpulsation	Enhanced external counterpulsation	Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.
Control	Guideline-driven standard medical therapy	Guideline-driven standard medical therapy.

Primary Outcome Measures

Name	Time	Method
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction	up to 5 years

Secondary Outcome Measures

Name	Time	Method
vascular endothelial function	up to 5 years	measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
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
all-cause mortality	up to 5 years
revascularization rate	up to 5 years
rehospitalization rate	up to 5 years
rate of acute myocardial infarction	up to 5 years

Trial Locations

Locations (4)

The 5th Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Zhuhai, Guangdong, China

The 3rd Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The 1st Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The 2nd Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China