Ischemic Stroke
Conditions
Interventions
Two groups:External Counterpulsation 35 one-hour sessions over a 7 week period versus Enhanced external counterpulsation(EECP) is a safe, non-invasive, easily accessible and relatively cheap procedure
Sponsors
Division of Neurology, Department of Medicine & Therapeutics, CUHK
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Subject is aged not less than 18; 2) Subject is presented with clinical diagnosis of ischaemic stroke according to the WHO criteria; 3) Recent ischemic stroke is within 7 days of symptom onset; 4) Subject is found to have motor deficit as a result of stroke; 5) Subject has brain CT performed and results confirmed no evidence of intracerebral haemorrhage; 6) NIHSS is between 4 and 16 inclusive; 7) Pre-stroke mRS 0-1; 8) Evidence of large artery occlusive disease. If no diagnostic procedure is done before randomization, neuroimaging should be done within 3 days of randomisaton; 9) Subject or his/her legally acceptable representative is willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Subject is aged less than 18; 2) Subject has evidence for cardioembolic stroke such as atrial fibrillation and rheumatic heart disease; 3) Subject has evidence for haemorrhage on brain CT; 4) Subject has a history of intracerebral haemorrhage; 5) Subject has evidence for AVMs, AV fistula or aneurysm; 6) Subject has active malignancy; 7) Subject has no definite motor deficit; 8) Subject has a National Institutes of Health Stroke Scale (NIHSS) of less than 4 or greater than 16; 9) Subject has sustained hypertension (systolic >180mmHg or diastolic >100mmHg); 10) Subject is unlikely to be followed up at Week 12; 11) Subject has co-existing systemic diseases: renal failure (creatinine >300 umol/L, if known), cirrhosis, severe dementia or psychosis; 12) Subject has brain tumour or other significant non-ischaemic brain lesion on CT; 13) Subject has thrombocytopenia (platelet count<100,000/mm3, if known); 14) Subject is a pregnant female, a breast-feeding mother, is planning pregnancy during the course of the trial or has a positive urine pregnancy test immediately prior to randomisation; 15) Subject is participating in another clinical trial within 30 days before randomisation; 16) Subject or his/her legally acceptable representative is unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint ("good outcome") at 12 weeks defined as the overall surviving patients with mRS 0-2 (i.e. Bad outcome as death or mRS 3-5).; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS at end of Week 7 & 12; difference of NIHSS between baseline and Wk 12; Modified Rankin Scale at Week 7 & 12 (0-1 as "good outcome"); Barthel Index at Week 7 & 12; Mini-Mental State Examination at Week 7 & 12; Overall mortality at Week 12; Predefined group of patients with large artery disease and for all randomized patients (including those later find to have no LAD) Prespecified patient "on-treatment analysis" who at least 25 ECP sessions.;NIHSS;Modified Rankin Scale;Barthel Index;Mini-Mental State Examination;Overall mortality;Predefined group of patients with large artery disease and for all randomized patients (including those later find to have no LAD);Prespecified patient "on-treatment analysis" who at least 25 ECP sessions; | — |
Countries
China
Contacts
Public ContactDr. Ka Sing Wong
The Chinese University of Hong Kong, Prince of Wales Hospital
Outcome results
None listed