An interventional study of External Counter Pulsation (ECP) therapy in Counterpulsation and Angina Pectoris, sponsored by Universitas Padjadjaran. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Universitas Padjadjaran · Not applicable, Interventional, and Supportive care
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 84 is below the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →Universitas Padjadjaran is the lead sponsor of 93 studies on the registry; 23 are open to participants now.
Compared within Angina, Stable, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Angina Pectoris. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Device: External Counter Pulsation (ECP) therapy
Eligible stable angina pectoris patients in the control arm will receive no intervention therapy
ECP therapy consist of 36 session, each session @1 hour/day, five days a week with initial pressure of 300mmHg
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: At baseline and week 7 (post intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and week 7 (post intervention)
Myocardial Micro-alternation Index (MMI)
Myocardial Micro-alternation Index is part of ECG dispersion mapping (ECG-DM)
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: At baseline and week 7 (post intervention)
Major Adverse Cardiac Event (MACE)
Number of incidence of Major adverse cardiac event
Time frame: 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).
Time frame: At baseline and week 7 (post intervention)
Plan to share: No
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