Effectiveness of ECP Therapy in Stable Angina Pectoris Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitas Padjadjaran
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Congestive Heart Failure
Chronic heart failure with Functional Class NYHA III - IV
LVEF <35%
Unprotected left main stenosis >50%
Trial design
Design model
Parallel
Treatments tested in this trial
External Counter Pulsation (ECP) therapy
DeviceECP therapy consist of 36 session, each session @1 hour/day, five days a week with initial pressure of 300mmHg
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline and week 7 (post intervention)2
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF is a parameter captured through transthoracic echocardiography. LVEF was calculated by Simpson biplane method
Time frame
At baseline and week 7 (post intervention)3
Change in Time to mm ST-segment Depression
Time to induce significant ST-segment Depression using treadmill exercise test
Time frame
At baseline and week 7 (post intervention)4
Change in Duration of Treadmill Test
Maximally tolerated time of treadmill exercise test using Bruce protocol or Modified Bruce protocol
Time frame
At baseline and week 7 (post intervention)Secondary outcomes
1
Change in Summed Rest Score (SRS)
Summed Rest Score is part of myocardial perfusion parameters of SPECT myocardial perfusion defects examination. The score are accumulated from 17 polar map segment. each segment scored. the extent and severity of perfusion deficits while rest ranging from 0 to 4 with higher score mean worse clinical apperance.
Time frame
At baseline and week 7 (post intervention)2
Change in Summed Stress Score (SSS)
Summed Stress Score is part of myocardial perfusion parameters of SPECT myocardial perfusion defects examination. The score are accumulated from 17 polar map segment. each segment scored. the extent and severity of perfusion deficits while stress ranging from 0 to 4 with higher score mean worse clinical apperance.
Time frame
At baseline and week 7 (post intervention)3
Change in Summed Difference Score (SDS)
Summed Difference Score is part of myocardial perfusion parameters of SPECT myocardial perfusion defects examination. SDS can be calculated by subtracting the SRS from the SSS (SDS = SSS - SRS). This measure is used to describe the degree to which the deficit/ischemia is reversible. An SDS score of 0-1 indicates no ischemia; 2-4 points indicate mild ischemia; 5-6 points indicate moderate ischemia; while 7 or more points indicate severe ischemia.
Time frame
At baseline and week 7 (post intervention)4
Myocardial Micro-alternation Index (MMI)
Myocardial Micro-alternation Index is part of ECG dispersion mapping (ECG-DM)
Time frame
At baseline and week 7 (post intervention)Sponsors and contacts
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Source ClinicalTrials.gov