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Trial History Detail on 2007-11-14

CUHK_CCT00099

2006-03-15

Retrospective

1) Direct Grant for Research (Reference No. 2005.1.082) 2) Neurology Research Funding

Division of Neurology, Department of Medicine& Therapeutics, CUHK

N/A

Dr. Ka Sing Wong

Department of Medicine& Therapeutics

TEL: 2632-3144

Dr. Ka Sing Wong

Department of Medicine& Therapeutics

TEL: 2632-3471

Enhanced external counterpulsation(EECP) for atherosclerotic stroke study-A pilot study

EASY-Pilot

Yes

2004-04-13

Ischemic Stroke

Device

External Counterpulsation

35 one- hour sessions over a 7 week period

External couterpulsation operates by applying electrocadiogrm-triggerd diastolic pressure of approximately 250 mmHg to the calves, thighs, and buttocks by means of three air-filled cuffs. The effects of EECP are based on the intermittent, sequential inflation of the cuffs at the beginning of diastole and deflation at the end of the diastole. This results in an increase of arterial blood pressure and retrograde aortic blood flow during diastole (diastolic augmentation). At end-diastole, rapid, simultaneous deflation remove all the externally applied pressure to allow forward flow of blood, leaving behind an empty vascular bed in the lower limb to receive the output of the heart, therefore reducing systolic blood pressure(systolic unloading) and cardiac afterload.

Inclusion Criteria: 1)Patient is 18 or above. 2)Clinical evidence of cerebral infarct or transient ischaemic attack in preceding 6 months with relevant large artery occlusive disease at MRA examination. 3)Modified Rankin score (mRS) ≤ 3. 4)Normal platelet count and coagulation profile. 5)Signed informed consent. Exclusion Criteria: 1)Any medical condition that would not allow the patient to adhere to the protocol or complete the study. 2)Patients with hemorrhagic diathesis, concurrent anti-coagulation treatment, or history of primary intracranial hemorrhage. 3)Other non-ischemic intra-cerebral pathology, e.g. brain tumor, vascular malformation, etc. 4)Clinical evidence of arrhythmias, significant valvular heart disease on echocardiography, or aortic dissection. 5)Thrombophlebitis, ulcers or chronic skin infection of the lower limbs. 6)Clinical evidence of active malignancy. 7)Patients with pre-proliferative, or proliferative diabetic retinopathy.

Randomized

Active

Single-blind

Crossover

2004-05-03

50

Complete

change in NIHSS and cerebral blood Flow(CVIQ) at end of week 7 and 14

recurrent stroke Percentage of patients with favorable outcome (mRS≤, Barthel Index) at end of week 7 and 14

No

2009-11-30


Yes

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