Retrospective

Dr. Ka Sing Wong

Department of Medicine & Therapeutics

TEL: 2632-3144

xiongli@cuhk.edu.hk

Prince of Wales Hospital

Dr. Ka Sing Wong

Department of Medicine & Therapeutics

TEL: 2632-3471

ks-wong@cuhk.edu.hk

Prince of Wales Hospital

Yes

2007-05-04

Device

External Counterpulsation

35 one-hour sessions over a 7 week period

Enhanced external counterpulsation(EECP) is a safe, non-invasive, easily accessible and relatively cheap procedure. It uses sequential air cuffs filling in the calf, thigh and buttock to enhance diastolic pressure. It has been approved for the treatment of refractory angina worldwide. Its mechanism of action is thought to be diversion of blood from the lower extremities to the heart and brain and also promote collateral. In this proposal, we aim to confirm the efficacy and safety of external counterpulsation for the treatment of stroke patients with ischemic of atherosclerotic origin. Patients will be randomized to receive 35 one-hour sessions of ECP or no ECP, in addition to best available evidence-based medical and rehabilitation treatment.Neurological deficit, disability, recurrent events and safety will be documented on randomisation and 12 weeks after stroke onset.

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: 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 µmol/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.

18

No maximum

Both Male and Female

Randomized

Active

Open label

Parallel

No

Yes

N/A