Effectiveness of ECP Therapy in Stable Angina Pectoris Patients

NCT04873687 | Recruiting DMC

• 1 other identifier: Card-202103.01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Counterpulsation; Angina Pectoris

Keywords

External Counterpulsation; Stable Angina Pectoris; Indicated CABG; Global longitudinal strain; Ischemic response

Outcome Measures

Primary Outcomes (6)

• Change in Global Longitudinal Strain (GLS)

  GLS is a parameter captured through transthoracic echocardiography. GLS was calculated as the mean peak longitudinal systolic strain of all the LV segments, consistent with American Society of Echocardiography (ASE) guidelines.

  At baseline and week 7 (post intervention)

• Change in Left Ventricular Ejection Fraction (LVEF)

  LVEF is a parameter captured through transthoracic echocardiography. LVEF was calculated by Simpson biplane method

  At baseline and week 7 (post intervention)

• Change in Time to mm ST-segment Depression

  Time to induce significant ST-segment Depression using treadmill exercise test

  At baseline and week 7 (post intervention)

• Change in Duration of Treadmill Test

  Maximally tolerated time of treadmill exercise test using Bruce protocol or Modified Bruce protocol

  At baseline and week 7 (post intervention)

• Change in CCS score

  Degree of presenting chest pain symptoms using the Canadian cardiovascular society (CCS) class score. CCS class score ranging from 1 (mild) to 4 (severe)

  At baseline and week 7 (post intervention)

• Change in Seattle Angina Questionnaire (SAQ) Score

  Quality of life based on The Seattle Angina Questionnaire measurement. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.

  At baseline and week 7 (post intervention)

Secondary Outcomes (11)

• Change in Summed Rest Score (SRS)

  At baseline and week 7 (post intervention)

• Change in Summed Stress Score (SSS)

  At baseline and week 7 (post intervention)

• Change in Summed Difference Score (SDS)

  At baseline and week 7 (post intervention)

• Myocardial Micro-alternation Index (MMI)

  At baseline and week 7 (post intervention)

• The level of Vascular Endothelial Growth Factor (VEGF)

  At baseline and week 7 (post intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Device: External Counter Pulsation (ECP) therapy

Control

NO INTERVENTION

Eligible stable angina pectoris patients in the control arm will receive no intervention therapy

Interventions

External Counter Pulsation (ECP) therapy DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Dr. Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

RECRUITING

Related Publications (6)

• Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0.

  PMID: 10362181 BACKGROUND

• Wu E, Desta L, Brostrom A, Martensson J. 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. J Cardiovasc Nurs. 2020 Jul/Aug;35(4):375-385. doi: 10.1097/JCN.0000000000000638.

  PMID: 31929322 BACKGROUND

• Subramanian R, Nayar S, Meyyappan C, Ganesh N, Chandrakasu A, Nayar PG. Effect of Enhanced External Counter Pulsation Treatment on Aortic Blood Pressure, Arterial Stiffness and Ejection Fraction in Patients with Coronary Artery Disease. J Clin Diagn Res. 2016 Oct;10(10):OC30-OC34. doi: 10.7860/JCDR/2016/23122.8743. Epub 2016 Oct 1.

  PMID: 27891374 BACKGROUND

• Zhang C, Liu X, Wang X, Wang Q, Zhang Y, Ge Z. Efficacy of Enhanced External Counterpulsation in Patients With Chronic Refractory Angina on Canadian Cardiovascular Society (CCS) Angina Class: An Updated Meta-Analysis. Medicine (Baltimore). 2015 Nov;94(47):e2002. doi: 10.1097/MD.0000000000002002.

  PMID: 26632696 BACKGROUND

• Head SJ, da Costa BR, Beumer B, Stefanini GG, Alfonso F, Clemmensen PM, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Kappetein AP, Kastrati A, Knuuti J, Kolh P, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A, Windecker S, Juni P, Sousa-Uva M. Adverse events while awaiting myocardial revascularization: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):206-217. doi: 10.1093/ejcts/ezx115.

  PMID: 28472484 BACKGROUND

• Rampengan SH, Prihartono J, Siagian M, Immanuel S. The Effect of Enhanced External Counterpulsation Therapy and Improvement of Functional Capacity in Chronic Heart Failure patients: a Randomized Clinical Trial. Acta Med Indones. 2015 Oct;47(4):275-82.

  PMID: 26932695 BACKGROUND

MeSH Terms

Conditions

Angina Pectoris; Angina, Stable

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad R Akbar, MD, FIHA.

  Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad R Akbar, MD, FIHA.

CONTACT

+6281221040265; m.r.akbar@unpad.ac.id

Badai B Tiksnadi, MD, FIHA.

CONTACT

+628112237277; badai.bhatara.tiksnadi@unpad.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor and study statistician will not be aware of intervention assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiovascular Prevention and Rehabilitation Clinic Dr. Hasan Sadikin General Hospital

Model Details: The intervention will be administered to eligible stable angina pectoris patients Dr. Hasan Sadikin General Hospital in a randomized manner neither of experiment or control group.

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 5, 2021
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)