Effect of External Counter Pulsation on Ischemic Stroke

Eighth Affiliated Hospital, Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Ischemic Stroke

Treatments: Device: External counter pulsation (ECP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03075137

SYSU8002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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380 participants in 2 patient groups

External Counter Pulsation (ECP) group

Experimental group

Description:

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.

Treatment:

Device: External counter pulsation (ECP)

Control group

No Intervention group

Description:

Guideline-driven standard medical treatment