HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-08-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cardiac Rehabilitation Angiogenesis Refractory Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison between two groups

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

35 hours ECP treatment, initial treatment pressure is 75 mmHg

Group Type PLACEBO_COMPARATOR

External Counter Pulsation (ECP) therapy

Intervention Type DEVICE

35 hours ECP treatment in 35 sessions

Intervention Group

35 hours ECP treatment, initial treatment pressure is 300 mmHg

Group Type EXPERIMENTAL

External Counter Pulsation (ECP) therapy

Intervention Type DEVICE

35 hours ECP treatment in 35 sessions

Interventions

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External Counter Pulsation (ECP) therapy

35 hours ECP treatment in 35 sessions

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No