Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00355

2 Trial Registration Date

2013-01-18

i Registration Status

Prospective

3 Secondary IDs

CRE-2012.085

4 Source(s) of Funding

CUHK

5 Primary Sponsor

CUHK

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Chloe Kwok

ii Address

Centre for Clinical Research & Biostatistics, 5/F, Rm 501-502, School of Public Health, Prince of Wales Hospital, Sha Tin, NT

iii Phone

2252-8718

iv Email

chloekwok@cuhk.edu.hk

v Affiliation

CUHK

vi Country

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

i Name

Benny Zee

ii Address

Centre for Clinical Research & Biostatistics, 5/F, Rm 501-502, School of Public Health, Prince of Wales Hospital, Sha Tin, NT

iii Phone

2252-8865

iv Email

bzee@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

A cohort study for screening subclinical brain lesion for stroke and dementia using automated computerized retinal image analysis system for community-based elderly population in Hong Kong

10 Public Title

A cohort study for screening subclinical brain lesion for stroke and dementia using automated computerized retinal image analysis system for community-based elderly population in Hong Kong

i Public Title in Chinese 研究名稱

視網膜血管病變量化的電腦自動化分析系統作為長者早期隱性腦損害與中風和認知障礙症風險的快速診斷工具
—追蹤性的香港社區長者研究

11 Short Title (Optional)

NA

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-02-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Subclinical brain lesion for stroke and dementia

15 Intervention

i Types of intervention

Other

Please specify

NA

ii Description/ name of Intervention/article

NA

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

NA

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

NA

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

1) age ≥65;
2) recent MRI assessment/plan to have MRI assessment; and
3) written informed consent given.

ii Exclusion Criteria

1) history of clinical stroke or transient ischemic attack
2) dementia determined by the published cutoff values of the Chinese Mini Mental State Examination or medical history

iii Age Minimum

65

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-01-22

21 Target Sample Size

400

22 Recruitment Status

Recruiting

23 Primary Outcome

1. To evaluate if the automated computerized retinal imaging analysis system can predict subclinical brain lesion.

2. To determine if there are associations between retinal image and other clinical information such as MRI in which the data will be provided by other studies.

24 Secondary Outcome

NA

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-11-24

27 Primary Registry and Trial Identifying Number

ChiCTR-ODT-13003004

28 Date of Registration in Primary Registry

2013-01-18

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2015-08-12