NCT04873687 Effectiveness of ECP Therapy in Stable Angina Pectoris Patients
| NCT ID | NCT04873687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitas Padjadjaran |
| Condition | Counterpulsation |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2023-07-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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 * 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
Contact & Investigator
Mohammad R Akbar, MD, FIHA.
PRINCIPAL INVESTIGATOR
Universitas Padjadjaran
Frequently Asked Questions
Who can join the NCT04873687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Counterpulsation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04873687 currently recruiting?
Yes, NCT04873687 is actively recruiting participants. Contact the research team at m.r.akbar@unpad.ac.id for enrollment information.
Where is the NCT04873687 trial being conducted?
This trial is being conducted at Bandung, Indonesia.
Who is sponsoring the NCT04873687 clinical trial?
NCT04873687 is sponsored by Universitas Padjadjaran. The principal investigator is Mohammad R Akbar, MD, FIHA. at Universitas Padjadjaran. The trial plans to enroll 84 participants.