RecruitingNot ApplicableNCT04873687

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


Sponsor

Universitas Padjadjaran

Enrollment

84 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria22

  • 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

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Interventions

DEVICEExternal Counter Pulsation (ECP) therapy

ECP therapy consist of 36 session, each session @1 hour/day, five days a week with initial pressure of 300mmHg


Locations(1)

Dr. Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

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NCT04873687


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