ECP therapy for patients with stable angina waiting for CABG
Effectiveness of External Counter Pulsation (ECP) Therapy in Stable Angina Pectoris Patients; a Proof of Principal Clinical Trial
This study is testing if adding External Counterpulsation therapy can help people with stable angina feel better while they wait for heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, West Java) |
| Trial ID | NCT04873687 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of External Counterpulsation (ECP) therapy in patients with stable angina pectoris who are on a waiting list for coronary artery bypass grafting (CABG). The study aims to determine if adding ECP therapy to optimal medical treatment can relieve symptoms and improve quality of life during the waiting period. Participants will be randomized into two groups: one receiving ECP therapy and the other receiving standard medical therapy alone. The efficacy will be assessed through echocardiographic measurements, treadmill tests, and clinical outcomes before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with stable angina pectoris who are indicated for CABG and currently on the waiting list.
Not a fit: Patients with severe heart conditions such as congestive heart failure or those requiring urgent CABG will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life and reduce symptoms for patients awaiting CABG.
How similar studies have performed: While the use of ECP therapy has been explored in refractory angina, this specific application for patients awaiting CABG is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bandung, West Java
- Dr. Hasan Sadikin General Hospital — Bandung, West Java, Indonesia (Recruiting)
Study contacts
- Principal investigator: Mohammad R Akbar, MD, FIHA. — Universitas Padjadjaran
- Study coordinator: Mohammad R Akbar, MD, FIHA.
- Email: m.r.akbar@unpad.ac.id
- Phone: +6281221040265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.