Effectiveness of ECP Therapy in Stable Angina Pectoris Patients

Официальное название

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

Обзор

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.

Подробное описание

Waiting time for elective CABG procedure in Indonesia is usually longer than six weeks, way longer than the European society of cardiology recommendation. During the waiting time, patients still complain of having troubling chest pain and at risk from 1.7% mortality even after optimal medical therapy. ECP is a non-invasive therapy using a pressured cuff performed on patients that have been utilized in refractory angina pectoris patients to relieve symptoms, increase the quality of life, and decrease future major adverse cardiac events (MACE).

This study is proof of principal clinical trial to evaluate the efficacy of addition ECP therapy after optimal medical therapy for stable angina pectoris patients waiting for CABG in Dr. Hasan Sadikin General Hospital, Bandung, Indonesia. Eligible patients will be informed about the study and randomized to the intervention arm. Patients in the experimental arm will undergo ECP therapy consisting of 36 sessions, each session @1 hour/day, five days a week with an initial pressure of 300mmHg. No intervention will be given to patients in the control arm.

The primary and secondary endpoint is the change in variables measured before and after the intervention is fully implemented. The primary endpoint variables are global longitudinal strain (GLS), Left ventricular ejection fraction (LVEF), Time to ST-Segment depression, duration of treadmill test, the Canadian cardiovascular society (CCS) score, and the Seattle angina questionnaire (SAQ) score. The secondary endpoint variable will be myocardial perfusion score measured as Summed Rest Score, Summed Stress Score, Summed Difference Score, Myocardial Micro-alternation Index (MMI), the level of Vascular Endothelial Growth Factor (VEGF), microRNA-92a (miR-92a), NT pro BNP, Troponin, incidence of MACE, general quality of life based on questionnaire The Indonesian EQ-5D-5L, and effectiveness of ECP for stable angina pectoris patients with pharmaco-economy studies. This change will then be compared between the intervention experimental arm and control arm.

Safety oversight by a Data and Safety Monitoring Board (DSMB) will be conducted by independent parties. Internal Data Monitoring Committee (DMC) will be established to oversee the study, focused on data quality. Quality control (QC) procedures will be implemented beginning with the data entry system. Data QC checks that will be run on the database will be automatically generated weekly, and any quality issues identified will be reviewed by the DMC a plan put in place for resolution.

Вмешательства

• Устройство External Counter Pulsation (ECP) therapy
  ECP therapy consist of 36 session, each session @1 hour/day, five days a week with initial pressure of 300mmHg

Первичные конечные точки

• Change in Global Longitudinal Strain (GLS) [Срок оценки: At baseline and week 7 (post intervention)]
• Change in Left Ventricular Ejection Fraction (LVEF) [Срок оценки: At baseline and week 7 (post intervention)]
• Change in Time to mm ST-segment Depression [Срок оценки: At baseline and week 7 (post intervention)]
• Change in Duration of Treadmill Test [Срок оценки: At baseline and week 7 (post intervention)]
• Change in CCS score [Срок оценки: At baseline and week 7 (post intervention)]
• Change in Seattle Angina Questionnaire (SAQ) Score [Срок оценки: At baseline and week 7 (post intervention)]

Вторичные конечные точки (11)

• Change in Summed Rest Score (SRS) [Срок оценки: At baseline and week 7 (post intervention)]
• Change in Summed Stress Score (SSS) [Срок оценки: At baseline and week 7 (post intervention)]
• Change in Summed Difference Score (SDS) [Срок оценки: At baseline and week 7 (post intervention)]
• Myocardial Micro-alternation Index (MMI) [Срок оценки: At baseline and week 7 (post intervention)]
• The level of Vascular Endothelial Growth Factor (VEGF) [Срок оценки: At baseline and week 7 (post intervention)]
• The level of microRNA-92a (miR-92a) [Срок оценки: At baseline and week 7 (post intervention)]
• The level of NT pro BNP and Troponin [Срок оценки: At baseline and week 7 (post intervention)]
• The level of Troponin [Срок оценки: At baseline and week 7 (post intervention)]
• Change in Quality of Life [Срок оценки: At baseline and week 7 (post intervention)]
• Major Adverse Cardiac Event (MACE) [Срок оценки: 2 years]
• Effectiveness of ECP for stable angina pectoris patients [Срок оценки: At baseline and week 7 (post intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Индонезия · 1 центр

• Dr. Hasan Sadikin General Hospital — Bandung

Публикации

• 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
• 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
• 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
• 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
• 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 revie PMID 28472484
• 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

Идентификаторы

NCT: NCT04873687 · Card-202103.01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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