HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study

National Cardiovascular Center Harapan Kita Hospital Indonesia

Status: Unknown

Conditions: Cardiac Rehabilitation; Angiogenesis; Refractory Angina

Treatments: Device: External Counter Pulsation (ECP) therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03991871

HARTEC Study

Details and patient eligibility

About

External Counterpulsation Therapy (ECP) is a therapeutic procedure that performed on patients with angina or heart failure to relieve the ischaemic symptoms, improve functional capacity, and quality of life. In recent studies, ECP has already proved to reduce angina symptoms, decrease degree of ischemic in heart train test. External Counterpulsation Therapy (ECP) therapy is a non-invasive technique for sequentially pressuring calf, lower thighs, and upper thighs through developed cuffs at pressure above systolic blood pressure when diastole, then deflated at systole.

Full description

This study aims to evaluate the effect of ECP therapy on cardiovascular hemodynamic, coronary perfusion, endothelial function, angiogenesis and artery genesis of the coronary blood vessel to refractory angina pectoris patients Refractory angina pectoris patients in Harapan Kita hospitals who do not respond to drugs adequately will be divided by 2 groups, control & treatment. Inclusion criteria include age 21 - 80 years, Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medications).

Exclusion criteria include aorta aneurysm, abdominal aneurysm, acute coronary syndrome, acute heart failure, heavy aortic regurgitation, malignant arrhythmia, blood pressure above 180/100mmHg, acute limb ischemia, DVT, active thrombophlebitis, and pregnancy.

the investigator conducts a double-blind randomized control trial. The participants will get 35 hours ECP treatment, initial treatment pressure is 300 mmHg. whilst control groups will get 75mmHg. At the end of treatment, the investigator compare the hemodynamic effect on coronary perfusion, endothelial function, angiogenesis, and coronary blood vessel arteriogenesis. Quality of Life Improvement based on WHO-5 between groups

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 21 - 80 years
• Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medica mentosa).

Exclusion criteria

• aorta aneurysm,
• abdominalis aneurysm,
• acute coronary syndrome,
• acute heart failure,
• heavy aortic regurgitation,
• malignant arrhythmia,
• blood pressure above 180/100mmHg,
• acute limb ischaemia,
• DVT,
• active thrombophlebitis,
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

35 hours ECP treatment, initial treatment pressure is 75 mmHg

Treatment:

Device: External Counter Pulsation (ECP) therapy

Intervention Group

Experimental group

Description:

35 hours ECP treatment, initial treatment pressure is 300 mmHg

Treatment:

Device: External Counter Pulsation (ECP) therapy