Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00142

2 Trial Registration Date

2007-11-21

iRegistration Status

Retrospective

3 Secondary IDs

NIL

4 Source(s) of Funding

CUHK Neurology Fund

5 Primary Sponsor

Division of Neurology, Department of Medicine & Therapeutics, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Dr. Li XIONG

ii Address

Department of Medicine & Therapeutics

iii Phone

TEL: 2632-3144

iv Email

xiongli@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong, Prince of Wales Hospital

vi Country

Hong Kong

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

i Name

Dr. Ka Sing Wong

ii Address

Department of Medicine & Therapeutics

iii Phone

TEL: 2632-3471

iv Email

ks-wong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

A Multi-centre, Randomized, Controlled Study of External Counterpulsation for Patients with Recent Atherosclerotic Stroke

10 Public Title

A Multi-centre, Randomized, Controlled Study of External Counterpulsation for Patients with Recent Atherosclerotic Stroke

i Public Title in Chinese 研究名稱

NA

11 Short Title (Optional)

SPA

12 Countries of Recruitment

Hong Kong, SAR

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-05-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2007.197T

14 Medical Condition Being Studied

Ischemic Stroke

15Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

External Counterpulsation

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

35 one-hour sessions

vi Frequency of the intervention

over a 7 week period

16Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

35 one-hour sessions

v Frequency of the comparative treatments

over a 7 week period

17Key Inclusion and Exclusion Criteria

i 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.

ii 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 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.

iii Age Minimum

18

iv Age Maximum

No maximum

v Gender

Both Male and Female

18 Study Type

Observational

19Study Design

i Randomization

Randomized

Please specify

Prospective

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2007-05-01

21 Target Sample Size

250

22 Recruitment Status

Recruiting

23 Primary Outcome

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).

24 Secondary Outcome

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.

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2016-08-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-07000706

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail