Clinical trial NCT03991871: HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
Official title: HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Rehabilitation
Angiogenesis
Refractory Angina
Keywords: Refractory Angina
Angiogenesis
External Counterpulsation
Angiopoietin
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between two groups
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Angiopoietin I concentration
timeFrame: 7 weeks
measure: MiRNA 92a concentration
timeFrame: 7 weeks
measure: Angiopoietin II concentration
timeFrame: 7 weeks
Secondary outcomes:
measure: VEGFR-2 concentration
timeFrame: 7 weeks
measure: VEGF concentration
timeFrame: 7 weeks
measure: NT pro BNP concentration
timeFrame: 7 weeks
measure: 6 minute walking test distance (meters)
timeFrame: 7 weeks
measure: NYHA Class index
timeFrame: 7 weeks
measure: CCS Class index
timeFrame: 7 weeks
measure: WHO 5 index
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Ade Meidian Ambari
state: DKI Jakarta
Study officials:
affiliation: National Cardiovascular Center Harapan Kita Hospital Indonesia
name: Ade Meidian Ambari, MD,FIHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MC, Kini A, Sharma SK. Refractory angina pectoris: mechanism and therapeutic options. J Am Coll Cardiol. 2002 Mar 20;39(6):923-34. doi: 10.1016/s0735-1097(02)01716-3.
citation: Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.
citation: Henry TD, Satran D, Jolicoeur EM. Treatment of refractory angina in patients not suitable for revascularization. Nat Rev Cardiol. 2014 Feb;11(2):78-95. doi: 10.1038/nrcardio.2013.200. Epub 2013 Dec 24.
citation: Ambari AM, Lilihata G, Zuhri E, Ekawati E, Wijaya SA, Dwiputra B, Sukmawan R, Radi B, Haryana SM, Adiarto S, Hanafy DA, Zamroni D, Elen E, Mangkuanom AS, Santoso A. External Counterpulsation Improves Angiogenesis by Preserving Vascular Endothelial Growth Factor-A and Vascular Endothelial Growth Factor Receptor-2 but Not Regulating MicroRNA-92a Expression in Patients With Refractory Angina. Front Cardiovasc Med. 2021 Oct 25;8:761112. doi: 10.3389/fcvm.2021.761112. eCollection 2021.