Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00486

2 Trial Registration Date

2015-11-05

i Registration Status

Prospective

3 Secondary IDs

2015.524

4 Source(s) of Funding

NA

5 Primary Sponsor

The Chinese University Of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ms. Maria Lai

ii Address

Room 501-2, JC School of Public Health and Primary Care,
The Chinese University of Hong Kong,
Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

iii Phone

2252 8865

iv Email

marialai@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

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

i Name

Benny Zee

ii Address

Room 501-2, JC School of Public Health and Primary Care,
The Chinese University of Hong Kong,
Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

iii Phone

2252-8865

iv Email

bzee@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

A cohort study to assess the effect of stroke risk assessment using automatic retinal image analysis (ARIA) on the changes of lifestyle profile for community-based population in Hong Kong

10 Public Title

A cohort study to assess the effect of stroke risk assessment using automatic retinal image analysis (ARIA) on the changes of lifestyle profile for community-based population in Hong Kong

i Public Title in Chinese 研究名稱

以社區為基礎的隊列研究 - 使用全自動視網膜圖像分析（ARIA）來評估中風風險與生活方式的關系

11 Short Title (Optional)

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?

2015-09-29

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.524

14 Medical Condition Being Studied

Stroke Risk

15 Intervention

i Types of intervention

Other

Please specify

NA

ii Description/ name of Intervention/article

NA

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Age>18

Willing to sign the inform consent

Willing to comply with procedures required in the protocol

ii Exclusion Criteria

Age < 18

Poor retinal images quality that cannot be used in the analysis

Subjects with other eye diseases which are not suitable for retinal imaging, such as severe cataract, glaucoma, atretopsia, corneal plague.

Subjects are distress with flashlight or have experience with photosensitive seizure.

Unwillingness or inability to comply with procedures required in the protocol

iii Age Minimum

18

iv Age Maximum

NA

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

To carry out a cohort study in general population from the community to evaluate if there is association between the ARIA stroke risk using automatic retinal imaging analysis and lifestyle profile;To determine if there are associations between retinal image characteristics and other clinical informa

20 Anticipated trial start date

2015-11-12

21 Target Sample Size

2000

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Association between ARiA Stroke Risk and Health Promotion Lifestyle Profile

ii The metric or method of measurement used

ARIA Stroke Risk and HPLP Questionnaires

iii The timepoint(s) of primary interest

Yearly for 3 years

24 Secondary Outcome

i The Name of the outcome

NA

ii The metric or method of measurement used

NA

iii The timepoint(s) of primary interest

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-IIC-15007348

28 Date of Registration in Primary Registry

2015-11-05

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Trial History Detail on 2016-04-05