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出境医 / 临床实验 / HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study (HARTEC)

HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study (HARTEC)

Study Description
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.

Condition or disease Intervention/treatment Phase
Cardiac Rehabilitation Angiogenesis Refractory Angina Device: External Counter Pulsation (ECP) therapy Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison between two groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Control Group
35 hours ECP treatment, initial treatment pressure is 75 mmHg
 Device: External Counter Pulsation (ECP) therapy
35 hours ECP treatment in 35 sessions
Experimental: Intervention Group
35 hours ECP treatment, initial treatment pressure is 300 mmHg
 Device: External Counter Pulsation (ECP) therapy
35 hours ECP treatment in 35 sessions
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. VEGFR-2 concentration [ Time Frame: 7 weeks ]
    Vascular endothelial growth factor receptor-2 concentration, measured using ELISA

  2. VEGF concentration [ Time Frame: 7 weeks ]
    Vascular endothelial growth factor concentration, measured in plasma, using ELISA method

  3. 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.

  4. 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.

  5. 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.

  6. 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. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ade Meidian Ambari, MD,FIHA 628119644123 dr_ade_meidian@yahoo.co.id

Locations
Layout table for location information
Indonesia
Ade Meidian Ambari Recruiting
Jakarta, DKI Jakarta, Indonesia, 1140
Contact: Ade Meidian Ambari, MD,FIHA    021-5684085 ext 2209    dr_ade_meidian@yahoo.co.id   
Sponsors and Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
Investigators
Layout table for investigator information
Principal Investigator: Ade Meidian Ambari, MD,FIHA National Cardiovascular Center Harapan Kita Hospital Indonesia
Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2020)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019) 		Angiopoietin I [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2020)
  • VEGFR-2 concentration [ Time Frame: 7 weeks ]
    Vascular endothelial growth factor receptor-2 concentration, measured using ELISA
  • VEGF concentration [ Time Frame: 7 weeks ]
    Vascular endothelial growth factor concentration, measured in plasma, using ELISA method
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 6 minute walking test [ 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.
  • NT pro BNP [ 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
Official Title  ICMJE HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Comparison between two groups
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Rehabilitation
  • Angiogenesis
  • Refractory Angina
Intervention  ICMJE Device: External Counter Pulsation (ECP) therapy
35 hours ECP treatment in 35 sessions
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    35 hours ECP treatment, initial treatment pressure is 75 mmHg
    Intervention: Device: External Counter Pulsation (ECP) therapy
  • Experimental: Intervention Group
    35 hours ECP treatment, initial treatment pressure is 300 mmHg
    Intervention: Device: External Counter Pulsation (ECP) therapy
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. Review.
  • 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. Review. Erratum in: Nat Rev Cardiol. 2014 Feb;11(2):i.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020) 		50
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019) 		90
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ade Meidian Ambari, MD,FIHA 628119644123 dr_ade_meidian@yahoo.co.id
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991871
Other Study ID Numbers  ICMJE HARTEC Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bambang Dwiputra, National Cardiovascular Center Harapan Kita Hospital Indonesia
Study Sponsor  ICMJE National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ade Meidian Ambari, MD,FIHA National Cardiovascular Center Harapan Kita Hospital Indonesia
PRS Account National Cardiovascular Center Harapan Kita Hospital Indonesia
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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