Clinical trial NCT04873687: Effectiveness of ECP Therapy in Stable Angina Pectoris Patients
Official title: Effectiveness of External Counter Pulsation (ECP) Therapy in Stable Angina Pectoris Patients; a Proof of Principal Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Counterpulsation
Angina Pectoris
Keywords: External Counterpulsation
Stable Angina Pectoris
Indicated CABG
Global longitudinal strain
Ischemic response
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Global Longitudinal Strain (GLS)
timeFrame: At baseline and week 7 (post intervention)
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: At baseline and week 7 (post intervention)
measure: Change in Time to mm ST-segment Depression
timeFrame: At baseline and week 7 (post intervention)
measure: Change in Duration of Treadmill Test
timeFrame: At baseline and week 7 (post intervention)
measure: Change in CCS score
timeFrame: At baseline and week 7 (post intervention)
measure: Change in Seattle Angina Questionnaire (SAQ) Score
timeFrame: At baseline and week 7 (post intervention)
Secondary outcomes:
measure: Change in Summed Rest Score (SRS)
timeFrame: At baseline and week 7 (post intervention)
measure: Change in Summed Stress Score (SSS)
timeFrame: At baseline and week 7 (post intervention)
measure: Change in Summed Difference Score (SDS)
timeFrame: At baseline and week 7 (post intervention)
measure: Myocardial Micro-alternation Index (MMI)
timeFrame: At baseline and week 7 (post intervention)
measure: The level of Vascular Endothelial Growth Factor (VEGF)
timeFrame: At baseline and week 7 (post intervention)
measure: The level of microRNA-92a (miR-92a)
timeFrame: At baseline and week 7 (post intervention)
measure: The level of NT pro BNP and Troponin
timeFrame: At baseline and week 7 (post intervention)
measure: The level of Troponin
timeFrame: At baseline and week 7 (post intervention)
measure: Change in Quality of Life
timeFrame: At baseline and week 7 (post intervention)
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 2 years
measure: Effectiveness of ECP for stable angina pectoris patients
timeFrame: At baseline and week 7 (post intervention)
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Dr. Hasan Sadikin General Hospital
state: West Java
Study officials:
affiliation: Universitas Padjadjaran
name: Mohammad R Akbar, MD, FIHA.
role: PRINCIPAL_INVESTIGATOR
References:
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