NCT04873687Recruiting
Effectiveness of ECP Therapy in Stable Angina Pectoris Patients
Effectiveness of External Counter Pulsation (ECP) Therapy in Stable Angina Pectoris Patients; a Proof of Principal Clinical Trial
Source: ClinicalTrials.gov · Last updated 25 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 24 Apr 2021
- Start date
- 1 Jul 2023
- Primary completion date
- Dec 2024
- Lead sponsor
- Universitas Padjadjaran
- Diseases
- Coronary artery disease
- NCT number
- NCT04873687
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Jul 2023 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- LVEF \<35%
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Hasan Sadikin General Hospital Coordinator of this site? Confirm its status | Bandung | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.