Effect of External Counter Pulsation on Ischemic Stroke

Study Overview
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Brief Summary
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Stroke is a prevalent atherosclerosis vascular disease with high mortality, external counter pulsation (ECP) is an approved noninvasive therapy for angina, congestive heart failure, myocardial infarction, and cardiogenic shock that augments blood flow to cardiac and systemic circuits, which improves the flow volume in the carotid. Though ECP is Ⅱa recommendation for stroke management, no multi-center control clinical study has been reported for prognosis of stroke. The aim of this study is to evaluate the effect of ECP on stoke. To address this assumption, investigators enroll subjects with ischemic stroke and randomized into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks. The primary endpoint is mRS score in 3 months, secondary endpoints include NIHSS, BI and MMSE score, recurrence of stroke in 3 months, glycolipid metabolism, transcranial doppler (TCD) flow velocities and endothelial function.

Detailed Description
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Cardiovascular disease is the leading cause of mortality worldwide, accounting for 17.5 million deaths per year; 6.7 million of these deaths are related to stroke. Over 80% of strokes are classified as ischemic. External counter pulsation (ECP) is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved carotid perfusion pressure. Cumulative evidences demonstrate that ECP can augment peak diastolic and mean middle cerebral artery flow velocities, accelerate rehabilitation after stroke, however, no multi-center study on the effect of ECP on the prognosis of stroke has been reported. Thus, this study is designed to enroll 380 subjects with ischemic stroke after evaluation of glycolipid metabolism, heart function, transcranial doppler (TCD) flow velocities, endothelial function, NIHSS, BI and MMSE score, they will be randomized into ECP intervention or control group. All subjects receive Guideline-driven standard medical treatment, ECP will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks. Up to the end of ECP intervention, mRS of subjects will be follow up to 3 months, meanwhile, items as above will be retested for comparison.

Official Title
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Effect of External Counter Pulsation on IschemicStroke (ECP-STROKE)

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: External counter pulsation (ECP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ischemic stroke Exclusion cerebral hemorrhage after CT scan NIH Stroke Scale (NIHSS)≥4 Modified Rankin Scale (mRS) 0-1 Signed informed consent Exclusion Criteria: Obvious aortic insufficiency; Aortic aneurysm or aortic dissection; Coronary fistula or severe coronary aneurysm; Not controlled bleeding disease with INR>2.0 ; Symptomatic Congestive heart failure Valvular heart disease, congenital heart diseases, cardiomyopathies Cerebral hemorrhage within six months; Uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg; Lower limb infection; Deep venous thrombosis; Progressive malignancies or diseases with poor prognosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: External Counter Pulsation (ECP) group<br>A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. | Device: External counter pulsation (ECP)<br>* standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.<br>|
| No Intervention: Control group<br>Guideline-driven standard medical treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale （mRS） score | 3-month mRS score after stroke | Change from Baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH Stroke Scale (NIHSS) score | 3-month NIHSS score after stroke | Change from Baseline at 3 months | 
| Barthel Index (BI) | 3-month BI after stroke | Change from Baseline at 3 months | 
| mini-mental state examination (MMSE) Score | 3-month MMSE after stroke | Change from Baseline at 3 months | 
| Ischemic area of Cerebral CT image | Ischemic area of 3-month Cerebral CT image | Change from Baseline at 3 months | 
| Transcranial doppler (TCD) flow velocities | transcranial doppler (TCD) flow velocities | Change from Baseline at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, external counter pulsation, mRS