CounterpulsationNCT04873687
Effectiveness of ECP Therapy in Stable Angina Pectoris Patients
A study testing External Counter Pulsation (ECP) therapy in people with Counterpulsation and Angina Pectoris, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
External Counterpulsation (ECP) is a non-invasive therapy using pressured cuff that is performed on patients with refractory stable angina pectoris to relieve symptoms and increase quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Counterpulsation, Angina Pectoris
- What is being tested?
- External Counter Pulsation (ECP) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Diagnosed with stable angina pectoris
- Anatomic vessel disease (VD) lesion with 2VD/3VD
- Indicated for CABG and in waiting list of CABG procedure; or refuse for CABG and choose medical therapy only; or patients who are decided by the responsible doctor for medical treatment alone because of the high risks of CABG surgery.
- Not planned to urgent CABG
- Minimum optimal medical therapy within 2 weeks
Show all 9Show fewer
- Able and willing to sign informed consent and comply with study procedures
- The patient lives in Bandung City and its neighborhood
- Retired patient; or not actively working during working hours; or willing to take the time to participate in research.
Who cannot join
- Congestive Heart Failure
- Chronic heart failure with Functional Class NYHA III - IV
- LVEF <35%
- Unprotected left main stenosis >50%
- Blood pressure >180/110mmHg
- Acute coronary syndrome
Show all 22Show fewer
- Acute Heart Failure
- Severe aorta regurgitation
- Malignant arrhythmia
- Atrial fibrillation
- Premature ventricular complex
- Peripheral occlusive artery disease
- Phlebitis
- Deep vein thrombosis
- Hemorrhagic diathesis
- Severe chronic kidney disease
- Aortic aneurysm
- Abdominal aneurysm
- Osteoarthritis
- Low back pain
- Pregnancy
- Registered as other clinical study participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Hasan Sadikin General Hospital
Bandung, West Java, 40161
Badai B Tiksnadi, MD, FIHA, +62112237277, badai.bhatara.tiksnadi@unpad.ac.id
Badai B Tiksnadi, MD, FIHA
About this study
Official title: Effectiveness of External Counter Pulsation (ECP) Therapy in Stable Angina Pectoris Patients; a Proof of Principal Clinical Trial
External Counterpulsation (ECP) is a non-invasive therapy using pressured cuff that is performed on patients with refractory stable angina pectoris to relieve symptoms and increase quality of life. In Indonesia, waiting time for getting coronary artery bypass grafting (CABG) procedure for revascularization treatment in stable angina pectoris patients is way longer than international recommendation which correlates with increase morbidity and mortality during the waiting time. Utilization of ECP for such patients who wait for CABG procedure is still unclear. The investigator aim to evaluate efficacy of addition of ECP compared with medical therapy alone for this population. The efficacy is evaluated using measurement from echocardiography result, treadmill test result, and clinical outcome. if applicable, examination of myocardial perfusion using nuclear examination will also be performed.
Read the detailed description
Waiting time for elective CABG procedure in Indonesia is usually longer than six weeks, way longer than the European society of cardiology recommendation. During the waiting time, patients still complain of having troubling chest pain and at risk from 1.7% mortality even after optimal medical therapy. ECP is a non-invasive therapy using a pressured cuff performed on patients that have been utilized in refractory angina pectoris patients to relieve symptoms, increase the quality of life, and decrease future major adverse cardiac events (MACE).
This study is proof of principal clinical trial to evaluate the efficacy of addition ECP therapy after optimal medical therapy for stable angina pectoris patients waiting for CABG in Dr. Hasan Sadikin General Hospital, Bandung, Indonesia. Eligible patients will be informed about the study and randomized to the intervention arm. Patients in the experimental arm will undergo ECP therapy consisting of 36 sessions, each session @1 hour/day, five days a week with an initial pressure of 300mmHg. No intervention will be given to patients in the control arm.
The primary and secondary endpoint is the change in variables measured before and after the intervention is fully implemented. The primary endpoint variables are global longitudinal strain (GLS), Left ventricular ejection fraction (LVEF), Time to ST-Segment depression, duration of treadmill test, the Canadian cardiovascular society (CCS) score, and the Seattle angina questionnaire (SAQ) score. The secondary endpoint variable will be myocardial perfusion score measured as Summed Rest Score, Summed Stress Score, Summed Difference Score, Myocardial Micro-alternation Index (MMI), the level of Vascular Endothelial Growth Factor (VEGF), microRNA-92a (miR-92a), NT pro BNP, Troponin, incidence of MACE, general quality of life based on questionnaire The Indonesian EQ-5D-5L, and effectiveness of ECP for stable angina pectoris patients with pharmaco-economy studies. This change will then be compared between the intervention experimental arm and control arm.
Safety oversight by a Data and Safety Monitoring Board (DSMB) will be conducted by independent parties. Internal Data Monitoring Committee (DMC) will be established to oversee the study, focused on data quality. Quality control (QC) procedures will be implemented beginning with the data entry system. Data QC checks that will be run on the database will be automatically generated weekly, and any quality issues identified will be reviewed by the DMC a plan put in place for resolution.
- Conditions
- Counterpulsation, Angina Pectoris
- Being tested
- External Counter Pulsation (ECP) therapy
- Keywords
- External Counterpulsation, Stable Angina Pectoris, Indicated CABG, Global longitudinal strain, Ischemic response
- Medical subject headings
- Angina Pectoris, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Counter Pulsation (ECP) therapyDevice
ECP therapy consist of 36 session, each session @1 hour/day, five days a week with initial pressure of 300mmHg
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will comprise study participants who receive intervention therapy (i.e eligible stable angina pectoris patients in intervention arm who agree to participate) Receives: Device: External Counter Pulsation (ECP) therapy |
| Control | No intervention | Eligible stable angina pectoris patients in the control arm will receive no intervention therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Longitudinal Strain (GLS)
GLS is a parameter captured through transthoracic echocardiography. GLS was calculated as the mean peak longitudinal systolic strain of all the LV segments, consistent with American Society of Echocardiography (ASE) guidelines.
Measured: At baseline and week 7 (post intervention)
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF is a parameter captured through transthoracic echocardiography. LVEF was calculated by Simpson biplane method
Measured: At baseline and week 7 (post intervention)
Change in Time to mm ST-segment Depression
Time to induce significant ST-segment Depression using treadmill exercise test
Measured: At baseline and week 7 (post intervention)
Change in Duration of Treadmill Test
Maximally tolerated time of treadmill exercise test using Bruce protocol or Modified Bruce protocol
Measured: At baseline and week 7 (post intervention)
Change in CCS score
Degree of presenting chest pain symptoms using the Canadian cardiovascular society (CCS) class score. CCS class score ranging from 1 (mild) to 4 (severe)
Measured: At baseline and week 7 (post intervention)
Change in Seattle Angina Questionnaire (SAQ) Score
Quality of life based on The Seattle Angina Questionnaire measurement. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.
Measured: At baseline and week 7 (post intervention)
Secondary outcomes (11)
Change in Summed Rest Score (SRS)
Summed Rest Score is part of myocardial perfusion parameters of SPECT myocardial perfusion defects examination. The score are accumulated from 17 polar map segment. each segment scored. the extent and severity of perfusion deficits while rest ranging from 0 to 4 with higher score mean worse clinical apperance.
Measured: At baseline and week 7 (post intervention)
Change in Summed Stress Score (SSS)
Summed Stress Score is part of myocardial perfusion parameters of SPECT myocardial perfusion defects examination. The score are accumulated from 17 polar map segment. each segment scored. the extent and severity of perfusion deficits while stress ranging from 0 to 4 with higher score mean worse clinical apperance.
Measured: At baseline and week 7 (post intervention)
Change in Summed Difference Score (SDS)
Summed Difference Score is part of myocardial perfusion parameters of SPECT myocardial perfusion defects examination. SDS can be calculated by subtracting the SRS from the SSS (SDS = SSS - SRS). This measure is used to describe the degree to which the deficit/ischemia is reversible. An SDS score of 0-1 indicates no ischemia; 2-4 points indicate mild ischemia; 5-6 points indicate moderate ischemia; while 7 or more points indicate severe ischemia.
Measured: At baseline and week 7 (post intervention)
Myocardial Micro-alternation Index (MMI)
Myocardial Micro-alternation Index is part of ECG dispersion mapping (ECG-DM)
Measured: At baseline and week 7 (post intervention)
The level of Vascular Endothelial Growth Factor (VEGF)
Blood tests were carried out to determine levels of VEGF using ELISA and quantitative reverse transcription-polymerase chain reaction (qRT-PCR). The measurement unit is pg/ml.
Measured: At baseline and week 7 (post intervention)
The level of microRNA-92a (miR-92a)
Blood tests were carried out to determine levels of miR-92a using ELISA and quantitative reverse transcription-polymerase chain reaction (qRT-PCR).
Measured: At baseline and week 7 (post intervention)
The level of NT pro BNP and Troponin
Blood tests were carried out to determine levels of NT pro BNP (measurement unit pg/ml).
Measured: At baseline and week 7 (post intervention)
The level of Troponin
Blood tests were carried out to determine levels of Troponin (measurement unit ng/ml).
Measured: At baseline and week 7 (post intervention)
Change in Quality of Life
Quality of life based on Questionnaire The Indonesian EQ-5D-5L, is a questionnaire used to assess the quality of life of angina pectoris patients undergoing ECP treatment, allowing us to determine how much money can be saved in extending a patient's life for one year. It consists of five assessment domains, which are walking ability, self-care, usual activities, pain/discomfort, and anxiety/depression. The normal range is 0-1, with a score of 1 indicating the best quality of life.
Measured: At baseline and week 7 (post intervention)
Major Adverse Cardiac Event (MACE)
Number of incidence of Major adverse cardiac event
Measured: 2 years
Effectiveness of ECP for stable angina pectoris patients
Effectiveness of ECP for stable angina pectoris patients is based on pharmacoeconomics. The assessment will use the ICER formula, comparing optimal medication therapy from both healthcare and national insurance perspectives, taking into account about nominal outcomes, clinical outcomes, and patient quality of life outcomes. The results from the formula will then be input into a diagram to determine whether they fall into quadrant 1, 2, 3, or 4 (the best outcome is if it falls into quadrant 2).
Measured: At baseline and week 7 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CounterpulsationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be administered to eligible stable angina pectoris patients Dr. Hasan Sadikin General Hospital in a randomized manner neither of experiment or control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Badai Bhatara Tiksnadi, Universitas Padjadjaran
- Investigators
- Mohammad R Akbar, MD, FIHA., Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873687
- Sponsor's protocol ID
- Card-202103.01
- Status last verified
- Sep 2023
- First submitted
- 24 Apr 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0.
PubMed 10362181Wu E, Desta L, Brostrom A, Martensson J. Effectiveness of Enhanced External Counterpulsation Treatment on Symptom Burden, Medication Profile, Physical Capacity, Cardiac Anxiety, and Health-Related Quality of Life in Patients With Refractory Angina Pectoris. J Cardiovasc Nurs. 2020 Jul/Aug;35(4):375-385. doi: 10.1097/JCN.0000000000000638.
PubMed 31929322Subramanian R, Nayar S, Meyyappan C, Ganesh N, Chandrakasu A, Nayar PG. Effect of Enhanced External Counter Pulsation Treatment on Aortic Blood Pressure, Arterial Stiffness and Ejection Fraction in Patients with Coronary Artery Disease. J Clin Diagn Res. 2016 Oct;10(10):OC30-OC34. doi: 10.7860/JCDR/2016/23122.8743. Epub 2016 Oct 1.
PubMed 27891374Zhang C, Liu X, Wang X, Wang Q, Zhang Y, Ge Z. Efficacy of Enhanced External Counterpulsation in Patients With Chronic Refractory Angina on Canadian Cardiovascular Society (CCS) Angina Class: An Updated Meta-Analysis. Medicine (Baltimore). 2015 Nov;94(47):e2002. doi: 10.1097/MD.0000000000002002.
PubMed 26632696Head SJ, da Costa BR, Beumer B, Stefanini GG, Alfonso F, Clemmensen PM, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Kappetein AP, Kastrati A, Knuuti J, Kolh P, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A, Windecker S, Juni P, Sousa-Uva M. Adverse events while awaiting myocardial revascularization: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):206-217. doi: 10.1093/ejcts/ezx115.
PubMed 28472484Rampengan SH, Prihartono J, Siagian M, Immanuel S. The Effect of Enhanced External Counterpulsation Therapy and Improvement of Functional Capacity in Chronic Heart Failure patients: a Randomized Clinical Trial. Acta Med Indones. 2015 Oct;47(4):275-82.
PubMed 26932695
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of External Counter Pulsation (ECP) Therapy in Stable Angina Pectoris Patients; a Proof of Principal Clinical Trial
- ClinicalTrials.gov ID
- NCT04873687
- Acronym / sponsor ID
- Card-202103.01
- Conditions
- Counterpulsation, Angina Pectoris
- Keywords
- External Counterpulsation, Stable Angina Pectoris, Indicated CABG, Global longitudinal strain, Ischemic response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
External Counterpulsation (ECP) is a non-invasive therapy using pressured cuff that is performed on patients with refractory stable angina pectoris to relieve symptoms and increase quality of life. In Indonesia, waiting time for getting coronary artery bypass grafting (CABG) procedure for revascularization treatment in stable angina pectoris patients is way longer than international recommendation which correlates with increase morbidity and mortality during the waiting time. Utilization of ECP for such patients who wait for CABG procedure is still unclear. The investigator aim to evaluate efficacy of addition of ECP compared with medical therapy alone for this population. The efficacy is evaluated using measurement from echocardiography result, treadmill test result, and clinical outcome. if applicable, examination of myocardial perfusion using nuclear examination will also be performed.
Detailed description
Waiting time for elective CABG procedure in Indonesia is usually longer than six weeks, way longer than the European society of cardiology recommendation. During the waiting time, patients still complain of having troubling chest pain and at risk from 1.7% mortality even after optimal medical therapy. ECP is a non-invasive therapy using a pressured cuff performed on patients that have been utilized in refractory angina pectoris patients to relieve symptoms, increase the quality of life, and decrease future major adverse cardiac events (MACE).
This study is proof of principal clinical trial to evaluate the efficacy of addition ECP therapy after optimal medical therapy for stable angina pectoris patients waiting for CABG in Dr. Hasan Sadikin General Hospital, Bandung, Indonesia. Eligible patients will be informed about the study and randomized to the intervention arm. Patients in the experimental arm will undergo ECP therapy consisting of 36 sessions, each session @1 hour/day, five days a week with an initial pressure of 300mmHg. No intervention will be given to patients in the control arm.
The primary and secondary endpoint is the change in variables measured before and after the intervention is fully implemented. The primary endpoint variables are global longitudinal strain (GLS), Left ventricular ejection fraction (LVEF), Time to ST-Segment depression, duration of treadmill test, the Canadian cardiovascular society (CCS) score, and the Seattle angina questionnaire (SAQ) score. The secondary endpoint variable will be myocardial perfusion score measured as Summed Rest Score, Summed Stress Score, Summed Difference Score, Myocardial Micro-alternation Index (MMI), the level of Vascular Endothelial Growth Factor (VEGF), microRNA-92a (miR-92a), NT pro BNP, Troponin, incidence of MACE, general quality of life based on questionnaire The Indonesian EQ-5D-5L, and effectiveness of ECP for stable angina pectoris patients with pharmaco-economy studies. This change will then be compared between the intervention experimental arm and control arm.
Safety oversight by a Data and Safety Monitoring Board (DSMB) will be conducted by independent parties. Internal Data Monitoring Committee (DMC) will be established to oversee the study, focused on data quality. Quality control (QC) procedures will be implemented beginning with the data entry system. Data QC checks that will be run on the database will be automatically generated weekly, and any quality issues identified will be reviewed by the DMC a plan put in place for resolution.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention will be administered to eligible stable angina pectoris patients Dr. Hasan Sadikin General Hospital in a randomized manner neither of experiment or control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: External Counter Pulsation (ECP) therapyThe intervention arm will comprise study participants who receive intervention therapy (i.e eligible stable angina pectoris patients in intervention arm who agree to participate) |
| Control | No intervention | –Eligible stable angina pectoris patients in the control arm will receive no intervention therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >= 18 years old
- Diagnosed with stable angina pectoris
- Anatomic vessel disease (VD) lesion with 2VD/3VD
- Indicated for CABG and in waiting list of CABG procedure; or refuse for CABG and choose medical therapy only; or patients who are decided by the responsible doctor for medical treatment alone because of the high risks of CABG surgery.
- Not planned to urgent CABG
Key exclusion criteria (22 listed)
- Congestive Heart Failure
- Chronic heart failure with Functional Class NYHA III - IV
- LVEF <35%
- Unprotected left main stenosis >50%
- Blood pressure >180/110mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Counter Pulsation (ECP) therapyECP therapy consist of 36 session, each session @1 hour/day, five days a week with initial pressure of 300mmHg | Device | Intervention |
Primary outcome
Change in Global Longitudinal Strain (GLS)
Time frame: At baseline and week 7 (post intervention)
GLS is a parameter captured through transthoracic echocardiography. GLS was calculated as the mean peak longitudinal systolic strain of all the LV segments, consistent with American Society of Echocardiography (ASE) guidelines.
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: At baseline and week 7 (post intervention)
LVEF is a parameter captured through transthoracic echocardiography. LVEF was calculated by Simpson biplane method
Change in Time to mm ST-segment Depression
Time frame: At baseline and week 7 (post intervention)
Time to induce significant ST-segment Depression using treadmill exercise test
Change in Duration of Treadmill Test
Time frame: At baseline and week 7 (post intervention)
Maximally tolerated time of treadmill exercise test using Bruce protocol or Modified Bruce protocol
Change in CCS score
Time frame: At baseline and week 7 (post intervention)
Degree of presenting chest pain symptoms using the Canadian cardiovascular society (CCS) class score. CCS class score ranging from 1 (mild) to 4 (severe)
Change in Seattle Angina Questionnaire (SAQ) Score
Time frame: At baseline and week 7 (post intervention)
Quality of life based on The Seattle Angina Questionnaire measurement. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.
11 secondary outcomes
Change in Summed Rest Score (SRS)
Time frame: At baseline and week 7 (post intervention)
Change in Summed Stress Score (SSS)
Time frame: At baseline and week 7 (post intervention)
Change in Summed Difference Score (SDS)
Time frame: At baseline and week 7 (post intervention)
Myocardial Micro-alternation Index (MMI)
Time frame: At baseline and week 7 (post intervention)
The level of Vascular Endothelial Growth Factor (VEGF)
Time frame: At baseline and week 7 (post intervention)
The level of microRNA-92a (miR-92a)
Time frame: At baseline and week 7 (post intervention)
The level of NT pro BNP and Troponin
Time frame: At baseline and week 7 (post intervention)
The level of Troponin
Time frame: At baseline and week 7 (post intervention)
Change in Quality of Life
Time frame: At baseline and week 7 (post intervention)
Major Adverse Cardiac Event (MACE)
Time frame: 2 years
Effectiveness of ECP for stable angina pectoris patients
Time frame: At baseline and week 7 (post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 10362181Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0.
- Background: PubMed 31929322Wu E, Desta L, Brostrom A, Martensson J. Effectiveness of Enhanced External Counterpulsation Treatment on Symptom Burden, Medication Profile, Physical Capacity, Cardiac Anxiety, and Health-Related Quality of Life in Patients With Refractory Angina Pectoris. J Cardiovasc Nurs. 2020 Jul/Aug;35(4):375-385. doi: 10.1097/JCN.0000000000000638.
- Background: PubMed 27891374Subramanian R, Nayar S, Meyyappan C, Ganesh N, Chandrakasu A, Nayar PG. Effect of Enhanced External Counter Pulsation Treatment on Aortic Blood Pressure, Arterial Stiffness and Ejection Fraction in Patients with Coronary Artery Disease. J Clin Diagn Res. 2016 Oct;10(10):OC30-OC34. doi: 10.7860/JCDR/2016/23122.8743. Epub 2016 Oct 1.
- Background: PubMed 26632696Zhang C, Liu X, Wang X, Wang Q, Zhang Y, Ge Z. Efficacy of Enhanced External Counterpulsation in Patients With Chronic Refractory Angina on Canadian Cardiovascular Society (CCS) Angina Class: An Updated Meta-Analysis. Medicine (Baltimore). 2015 Nov;94(47):e2002. doi: 10.1097/MD.0000000000002002.
- Background: PubMed 28472484Head SJ, da Costa BR, Beumer B, Stefanini GG, Alfonso F, Clemmensen PM, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Kappetein AP, Kastrati A, Knuuti J, Kolh P, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A, Windecker S, Juni P, Sousa-Uva M. Adverse events while awaiting myocardial revascularization: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):206-217. doi: 10.1093/ejcts/ezx115.
- Background: PubMed 26932695Rampengan SH, Prihartono J, Siagian M, Immanuel S. The Effect of Enhanced External Counterpulsation Therapy and Improvement of Functional Capacity in Chronic Heart Failure patients: a Randomized Clinical Trial. Acta Med Indones. 2015 Oct;47(4):275-82.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad R Akbar, MD, FIHA. principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Counter Pulsation (ECP) therapy in people with Counterpulsation and Angina Pectoris, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad R Akbar, MD, FIHA. (+6281221040265, m.r.akbar@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Longitudinal Strain (GLS) (time frame: At baseline and week 7 (post intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873687, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.