Tests external counterpulsation therapy in people with stable angina chest pain
Tests a pressure-cuff device added to usual medicine in adults with stable angina.
Plain-language title generated from the registry record
Registry title: Effectiveness of ECP Therapy in Stable Angina Pectoris Patients
Key facts
- Where
- Bandung, IndonesiaSee the site
Where in Indonesia
- Dr. Hasan Sadikin General HospitalBandung, IndonesiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitas Padjadjaran
- Trial code
- NCT04873687
- Record updated
- 25 September 2023
- Original description
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 full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: Congestive Heart Failure; Chronic heart failure with Functional Class NYHA III - IV; Acute coronary syndrome; Acute Heart Failure; Malignant arrhythmia; Peripheral occlusive artery disease; Deep vein thrombosis; Severe chronic kidney disease; LVEF <35%; Unprotected left main stenosis >50%; Blood pressure >180/110mmHg; Severe aorta regurgitation; Atrial fibrillation; Premature ventricular complex; Phlebitis; Hemorrhagic diathesis; Aortic aneurysm; Abdominal aneurysm; Osteoarthritis; Low back pain; Pregnancy; Registered as other clinical study participant.