HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study

NCT03991871 | Unknown DMC

• 1 other identifier: HARTEC Study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation; Angiogenesis; Refractory Angina

Keywords

Refractory Angina; Angiogenesis; External Counterpulsation; Angiopoietin

Outcome Measures

Primary Outcomes (3)

• Angiopoietin I concentration

  hemodynamic effect on coronary perfusion. angiopoietin I involve in angiogenesis process. this study aims to investigate effects of External counterpulsation for refractory angina patients. it hypothesized to increase collateral artery which mechanism is by increasing angiogenesis process, measured with increase of Angiopoietin I and decrease of Angiopoietin II. Angiopoietin I level will be measured using ELISA technique.

  7 weeks

• MiRNA 92a concentration

  microRNAs (miRNAs) are short (20-24 nt) non-coding RNAs that are involved in post-transcriptional regulation of gene expression in multicellular organisms by affecting both the stability and translation of mRNAs. miRNAs are transcribed by RNA polymerase II as part of capped and polyadenylated primary transcripts (pri-miRNAs) that can be either protein-coding or non-coding. The primary transcript is cleaved by the Drosha ribonuclease III enzyme to produce an approximately 70-nt stem-loop precursor miRNA (pre-miRNA), which is further cleaved by the cytoplasmic Dicer ribonuclease to generate the mature miRNA and antisense miRNA star (miRNA\*) products. The mature miRNA is incorporated into a RNA-induced silencing complex (RISC), which recognizes target mRNAs through imperfect base pairing with the miRNA and most commonly results in translational inhibition or destabilization of the target mRNA. inhibition of MiRNA 92a prevents endothelial dysfunction.

  7 weeks

• Angiopoietin II concentration

  Angiopoietin II established to play a role in blood vessel angiogenesis, antagonist of signaling through Tie2 tyrosine kinase receptor

  7 weeks

Secondary Outcomes (7)

• VEGFR-2 concentration

  7 weeks

• VEGF concentration

  7 weeks

• NT pro BNP concentration

  7 weeks

• 6 minute walking test distance (meters)

  7 weeks

• NYHA Class index

  7 weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

35 hours ECP treatment, initial treatment pressure is 75 mmHg

Device: External Counter Pulsation (ECP) therapy

Intervention Group

EXPERIMENTAL

35 hours ECP treatment, initial treatment pressure is 300 mmHg

Device: External Counter Pulsation (ECP) therapy

Interventions

External Counter Pulsation (ECP) therapy DEVICE

35 hours ECP treatment in 35 sessions

Control Group; Intervention Group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

Ade Meidian Ambari

Jakarta, DKI Jakarta, 1140, Indonesia

RECRUITING

Related Publications (4)

• 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.

  PMID: 11897431 RESULT

• 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.

  PMID: 18404725 RESULT

• 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.

  PMID: 24366073 RESULT

• 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.

  PMID: 34760951 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ade Meidian Ambari, MD,FIHA

  National Cardiovascular Center Harapan Kita Hospital Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ade Meidian Ambari, MD,FIHA

CONTACT

628119644123; dr_ade_meidian@yahoo.co.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Cardiologist

Model Details: Comparison between two groups

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: June 19, 2019
• Study Start: July 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)