- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03991871
HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study (HARTEC)
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ade Meidian Ambari, MD,FIHA
- Phone Number: 628119644123
- Email: dr_ade_meidian@yahoo.co.id
Study Locations
-
-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 1140
- Recruiting
- Ade Meidian Ambari
-
Contact:
- Ade Meidian Ambari, MD,FIHA
- Phone Number: 2209 021-5684085
- Email: dr_ade_meidian@yahoo.co.id
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Group
35 hours ECP treatment, initial treatment pressure is 75 mmHg
|
35 hours ECP treatment in 35 sessions
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Experimental: Intervention Group
35 hours ECP treatment, initial treatment pressure is 300 mmHg
|
35 hours ECP treatment in 35 sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Angiopoietin I concentration
Time Frame: 7 weeks
|
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
Time Frame: 7 weeks
|
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
Time Frame: 7 weeks
|
Angiopoietin II established to play a role in blood vessel angiogenesis, antagonist of signaling through Tie2 tyrosine kinase receptor
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VEGFR-2 concentration
Time Frame: 7 weeks
|
Vascular endothelial growth factor receptor-2 concentration, measured using ELISA
|
7 weeks
|
VEGF concentration
Time Frame: 7 weeks
|
Vascular endothelial growth factor concentration, measured in plasma, using ELISA method
|
7 weeks
|
NT pro BNP concentration
Time Frame: 7 weeks
|
Marker of heart failure.
NTpro BNP will be measured pre and post external counterpulsation.
BNP is actually produced primarily by the left ventricle of the heart (the heart's main pumping chamber).
It is associated with blood volume and pressure and with the work that the heart must do in pumping blood throughout the body.
Small amounts of a precursor protein, pro-BNP, are continuously produced by the heart.
Pro-BNP is then cleaved by the enzyme called corin to release the active hormone BNP and an inactive fragment, NT-proBNP, into the blood.When the left ventricle of the heart is stretched, the concentrations of BNP and NT-proBNP produced can increase markedly.
This situation indicates that the heart is working harder and having more trouble meeting the body's demands.
This may occur with heart failure as well as with other diseases that affect the heart and circulatory system.
|
7 weeks
|
6 minute walking test distance (meters)
Time Frame: 7 weeks
|
6 minutes walking test has long been known to measure functional capacity, will be measured pre and post ECP.
6-minutes walking test measuremet is in meter.
it measure how far the participants could walk in 6 minutes.
|
7 weeks
|
NYHA Class index
Time Frame: 7 weeks
|
New York Heart Association (NYHA) Functional Classification to classify severity of heart failure symptoms.
It places patients in one of four categories based on how much they are limited during physical activity.
|
7 weeks
|
CCS Class index
Time Frame: 7 weeks
|
Canadian Cardiovascular Society (CCS) classify angina symptoms into CCS class.
it is to classify severity of angina symptoms.
it places patients in one of four categories based on the severity of the angina on affecting and limiting phisical activity.
|
7 weeks
|
WHO 5 index
Time Frame: 7 weeks
|
measuring quality of life, it will be measured pre and post ECP.
The 5-item World Health Organization Well-Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being.
Since its first publication in 1998, the WHO-5 has been translated into more than 30 languages and has been used in research studies all over the world.
We now provide a systematic review of the literature on the WHO-5.
|
7 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ade Meidian Ambari, MD,FIHA, National Cardiovascular Center Harapan Kita Hospital Indonesia
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: Nat Rev Cardiol. 2014 Feb;11(2):i.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HARTEC Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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