Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04873687

Effectiveness of ECP Therapy in Stable Angina Pectoris Patients

Led by Universitas Padjadjaran · Updated on 2023-09-25

84

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effectiveness of ECP Therapy in Stable Angina Pectoris Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3e= 18 years old
  • Diagnosed with stable angina pectoris
  • Have anatomic vessel disease lesion with 2VD or 3VD
  • Indicated for CABG and on the waiting list; or refuse CABG and choose medical therapy only; or decided by doctor for medical therapy alone due to high CABG surgical risk
  • Not planned for urgent CABG
  • Received minimum optimal medical therapy for at least 2 weeks
  • Able and willing to sign informed consent and follow study procedures
  • Lives in Bandung City or its neighborhood
  • Retired, not actively working during working hours, or willing to take time to participate in research
Not Eligible

You will not qualify if you...

  • Congestive heart failure
  • Chronic heart failure with Functional Class NYHA III - IV
  • Left ventricular ejection fraction (LVEF) less than 35%
  • Unprotected left main stenosis greater than 50%
  • Blood pressure higher than 180/110 mmHg
  • 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 participant in another clinical study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dr. Hasan Sadikin General Hospital

Bandung, West Java, Indonesia, 40161

Actively Recruiting

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Research Team

M

Mohammad R Akbar, MD, FIHA.

CONTACT

B

Badai B Tiksnadi, MD, FIHA.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Effectiveness of ECP Therapy in Stable Angina Pectoris Patients | DecenTrialz