Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00099

2 Trial Registration Date

2006-03-15

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

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

5 Primary Sponsor

Division of Neurology, Department of Medicine& Therapeutics, CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Ka Sing Wong

ii Address

iii Phone

Department of Medicine& Therapeutics

iv Email

TEL: 2632-3144

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Ka Sing Wong

ii Address

iii Phone

Department of Medicine& Therapeutics

iv Email

TEL: 2632-3471

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

EASY-Pilot

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-04-13

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Ischemic Stroke

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

External Counterpulsation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

35 one- hour sessions over a 7 week period

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-05-03

21 Target Sample Size

50

22 Recruitment Status

Complete

23 Primary Outcome

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

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-30

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2007-11-14