Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease (PROBE-EECP)

Sun Yat-sen University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: Enhanced external counterpulsation; Drug: Guideline-driven standard medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01198405

SYSU-5010-2008

Details and patient eligibility

About

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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,050 participants in 2 patient groups

Enhanced External Counterpulsation

Experimental group

Description:

Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.

Treatment:

Device: Enhanced external counterpulsation

Control

Active Comparator group

Description:

Guideline-driven standard medical therapy.

Treatment:

Drug: Guideline-driven standard medical therapy