Effectiveness of External Counter Pulsation (ECP) Therapy in Stable Angina Pectoris Patients; a Proof of Principal Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Dr. Hasan Sadikin General Hospital
RECRUITING
Bandung
Contact Information
Primary
Mohammad R Akbar, MD, FIHA.
m.r.akbar@unpad.ac.id
+6281221040265
Backup
Badai B Tiksnadi, MD, FIHA.
badai.bhatara.tiksnadi@unpad.ac.id
+628112237277
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 84
Treatments
Experimental: Intervention
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)
No_intervention: Control
Eligible stable angina pectoris patients in the control arm will receive no intervention therapy
Sponsors
Leads: Universitas Padjadjaran

This content was sourced from clinicaltrials.gov