Clinical trial NCT03075137: Effect of External Counter Pulsation on Ischemic Stroke
Official title: Effect of External Counter Pulsation on IschemicStroke (ECP-STROKE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ischemic Stroke
Keywords: ischemic stroke
external counter pulsation
mRS
Lead sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen Research Institute, The Chinese University Hong Kong
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Second Affiliated Hospital of Zhengzhou University
First posted: 2017-03-09
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: modified Rankin Scale （mRS） score
timeFrame: Change from Baseline at 3 months
Secondary outcomes:
measure: NIH Stroke Scale (NIHSS) score
timeFrame: Change from Baseline at 3 months
measure: Barthel Index (BI)
timeFrame: Change from Baseline at 3 months
measure: mini-mental state examination (MMSE) Score
timeFrame: Change from Baseline at 3 months
measure: Ischemic area of Cerebral CT image
timeFrame: Change from Baseline at 3 months
measure: Transcranial doppler (TCD) flow velocities
timeFrame: Change from Baseline at 3 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Research Institute, The Chinese University Hong Kong
state: Guangdong
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
Study officials:
affiliation: Eighth Affiliated Hospital, Sun Yat-sen University
name: Guifu Wu, PhD
role: STUDY_CHAIR
References: