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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Control | No Intervention | Eligible stable angina pectoris patients in the control arm will receive no intervention therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Counter Pulsation (ECP) therapy | Device | ECP therapy consist of 36 session, each session @1 hour/day, five days a week with initial pressure of 300mmHg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and week 7 (post intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad R Akbar, MD, FIHA. | Contact | +6281221040265 | m.r.akbar@unpad.ac.id | |
| Badai B Tiksnadi, MD, FIHA. | Contact | +628112237277 | badai.bhatara.tiksnadi@unpad.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Mohammad R Akbar, MD, FIHA. | Universitas Padjadjaran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Hasan Sadikin General Hospital | Recruiting | Bandung | West Java | 40161 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10362181 | Background | 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. | |
| 31929322 | Background |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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Outcome assessor and study statistician will not be aware of intervention assignment
| 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. | 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. | At baseline and week 7 (post intervention) |
| Myocardial Micro-alternation Index (MMI) | Myocardial Micro-alternation Index is part of ECG dispersion mapping (ECG-DM) | 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. | 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). | 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). | 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). | 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. | At baseline and week 7 (post intervention) |
| Major Adverse Cardiac Event (MACE) | Number of incidence of Major adverse cardiac event | 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). | At baseline and week 7 (post intervention) |
| Wu 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. |
| 27891374 | Background | Subramanian 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. |
| 26632696 | Background | Zhang 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. |
| 28472484 | Background | Head 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. |
| 26932695 | Background | Rampengan 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. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |