Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04873687

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

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

84

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of adding External Counterpulsation (ECP) therapy to standard medical treatment for patients with stable angina pectoris who are waiting for coronary artery bypass grafting (CABG) surgery. The study addresses the longer waiting times for CABG in Indonesia, which may increase risks during this period. The goal is to assess whether ECP can relieve symptoms and improve heart function and quality of life in these patients. Participants will be randomly assigned to either the intervention group receiving ECP therapy or the control group receiving only medical treatment. ECP therapy involves 36 sessions, each lasting one hour, conducted five days a week with an initial pressure of 300mmHg. The control group will not receive this therapy. The study will compare changes in heart function and symptoms between the two groups. Participants will undergo assessments before and after the seven-week intervention period, including echocardiography, treadmill tests, and questionnaires measuring angina severity and quality of life. Additional tests may include nuclear myocardial perfusion imaging and blood tests for heart-related biomarkers. Researchers will monitor major adverse cardiac events over two years and perform safety oversight. The total study duration includes the seven-week intervention and long-term follow-up for safety and effectiveness.

CONDITIONS

Brief 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 60; 18 years old
  • Diagnosed with stable angina pectoris
  • Anatomic vessel disease with 2VD or 3VD
  • Indicated for CABG and on waiting list; or refused CABG and chose medical therapy; or assigned to medical treatment alone due to high CABG risk
  • Not planned for urgent CABG
  • On minimum optimal medical therapy for at least 2 weeks
  • Able and willing to sign informed consent and comply with study procedures
  • Lives in Bandung City or neighboring areas
  • Retired, not actively working during working hours, or willing to take time for study participation
Not Eligible

You will not qualify if you...

  • Congestive Heart Failure
  • Chronic heart failure with NYHA Class III or IV
  • Left ventricular ejection fraction less than 35%
  • Unprotected left main stenosis greater than 50%
  • Blood pressure higher than 180/110 mmHg
  • Acute coronary syndrome
  • Acute heart failure
  • Severe aortic 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 participant in another clinical study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Approximately 7 weeks

Participants in the intervention arm undergo External Counter Pulsation (ECP) therapy consisting of 36 sessions, each session lasting about 1 hour per day, five days a week. Participants in the control arm receive no intervention therapy.

36 sessions over 7 weeks (in-person)

Post-intervention Assessment

Duration - Short period immediately after intervention

Participants have assessments to evaluate changes in heart function, angina symptoms, quality of life, and other health markers before and after the intervention period.

2 visits (baseline and post-intervention assessments)

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for major adverse cardiac events (MACE) and overall health outcomes for up to 2 years following the intervention.

Periodic follow-up visits over 2 years

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.

B

Badai B Tiksnadi, MD, FIHA.

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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Published Research Related To This Trial

The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes.

R R Arora, T M Chou, D Jain...

https://pubmed.ncbi.nlm.nih.gov/10362181

Effectiveness of Enhanced External Counterpulsation Treatment on Symptom Burden, Medication Profile, Physical Capacity, Cardiac Anxiety, and Health-Related Quality of Life in Patients With Refractory Angina Pectoris.

Eline Wu, Liyew Desta, Anders Broström...

https://pubmed.ncbi.nlm.nih.gov/31929322

Effect of Enhanced External Counter Pulsation Treatment on Aortic Blood Pressure, Arterial Stiffness and Ejection Fraction in Patients with Coronary Artery Disease.

Ramasamy Subramanian, Sushma Nayar, Chokkalingam Meyyappan...

https://pubmed.ncbi.nlm.nih.gov/27891374

Efficacy of Enhanced External Counterpulsation in Patients With Chronic Refractory Angina on Canadian Cardiovascular Society (CCS) Angina Class: An Updated Meta-Analysis.

Chunmei Zhang, Xiangjuan Liu, Xiaomeng Wang...

https://pubmed.ncbi.nlm.nih.gov/26632696

The Effect of Enhanced External Counterpulsation Therapy and Improvement of Functional Capacity in Chronic Heart Failure patients: a Randomized Clinical Trial.

Starry H Rampengan, Joedo Prihartono, Minarma Siagian...

https://pubmed.ncbi.nlm.nih.gov/26932695