Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00571

2 Trial Registration Date

2017-12-07

i Registration Status

Prospective

3 Secondary IDs

None

4 Source(s) of Funding

nil

5 Primary Sponsor

Yuen Ying Tin

6 Secondary Sponsor

None

Function

Not Applicable

Please specify

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

i Name

Yuen Ying Tin

ii Address

Wong Siu Ching Family Medicine Clinic
1 Po Wu Lane
Tai Po
N.T.
Hong Kong

iii Phone

26523707

iv Email

tyy102@ha.org.hk

v Affiliation

Department of Family Medicine of New Territories East Cluster, Hospital Authority

vi Country

Hong Kong

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

i Name

Yuen Ying Tin

ii Address

Wong Siu Ching Family Medicine Clinic
1 Po Wu Lane
Tai Po
N.T.
Hong Kong

iii Phone

26523707

iv Email

tyy102@ha.org.hk

v Affiliation

Department of Family Medicine of New Territories East Cluster, Hospital Authority

vi Country

Hong Kong

9 Official Scientific Title of the Study

Prevalence of Major Electrocardiographic Abnormalities in Patients with Hypertension in Primary Care in Hong Kong

10 Public Title

Prevalence of Major Electrocardiographic Abnormalities in Patients with Hypertension in Primary Care in Hong Kong

i Public Title in Chinese 研究名稱

高血壓患者的心電圖異常率研究

11 Short Title (Optional)

nil

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?

2017-10-09

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.432

14 Medical Condition Being Studied

Hypertension

15 Intervention

i Types of intervention

Other

Please specify

ECG

ii Description/ name of Intervention/article

ECG in hypertensive patients

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

Not applicable

vi Frequency of the intervention

Once only

16 Comparative Treatments

i Description/ name of comparative treatments

None

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Not applicable

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patient with hypertension

Regularly followed up in General Outpatient Clinic

Either on lifestyle modification only, or together receiving anti-hypertensive drug

ii Exclusion Criteria

Diabetes

Bed bound

Known ischemic heart disease

Incomplete or missing data

Patient incapable of giving free informed consent

iii Age Minimum

18

iv Age Maximum

80

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

Not Applicable

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-12-07

21 Target Sample Size

500

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

To determine the prevalence of major ECG abnormalities among patients with hypertension who are followed up in primary care setting

ii The metric or method of measurement used

ECG changes

iii The timepoint(s) of primary interest

Not applicable

24 Secondary Outcome

i The Name of the outcome

None

ii The metric or method of measurement used

Not applicable

iii The timepoint(s) of primary interest

Not applicable

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-08-30

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-05-24