Effectiveness of External Counter Pulsation (ECP) Therapy in Stable Angina Pectoris Patients; a Proof of Principal Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in Time to mm ST-segment Depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor and study statistician will not be aware of intervention assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Time to mm ST-segment Depression
时间窗: At baseline and week 7 (post intervention)
Time to induce significant ST-segment Depression using treadmill exercise test
Change in Global Longitudinal Strain (GLS)
时间窗: At baseline and week 7 (post intervention)
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.
Change in Duration of Treadmill Test
时间窗: At baseline and week 7 (post intervention)
Maximally tolerated time of treadmill exercise test using Bruce protocol or Modified Bruce protocol
Change in CCS score
时间窗: At baseline and week 7 (post intervention)
Degree of presenting chest pain symptoms using the Canadian cardiovascular society (CCS) class score. CCS class score ranging from 1 (mild) to 4 (severe)
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: At baseline and week 7 (post intervention)
LVEF is a parameter captured through transthoracic echocardiography. LVEF was calculated by Simpson biplane method
Change in Seattle Angina Questionnaire (SAQ) Score
时间窗: At baseline and week 7 (post intervention)
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.
次要结局
- Change in Summed Difference Score (SDS)(At baseline and week 7 (post intervention))
- The level of Vascular Endothelial Growth Factor (VEGF)(At baseline and week 7 (post intervention))
- The level of microRNA-92a (miR-92a)(At baseline and week 7 (post intervention))
- The level of Troponin(At baseline and week 7 (post intervention))
- Change in Summed Rest Score (SRS)(At baseline and week 7 (post intervention))
- Myocardial Micro-alternation Index (MMI)(At baseline and week 7 (post intervention))
- Change in Quality of Life(At baseline and week 7 (post intervention))
- Major Adverse Cardiac Event (MACE)(2 years)
- Change in Summed Stress Score (SSS)(At baseline and week 7 (post intervention))
- The level of NT pro BNP and Troponin(At baseline and week 7 (post intervention))
- Effectiveness of ECP for stable angina pectoris patients(At baseline and week 7 (post intervention))
研究者
Badai Bhatara Tiksnadi
Head of Cardiovascular Prevention and Rehabilitation Clinic Dr. Hasan Sadikin General Hospital
Universitas Padjadjaran