Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00424

2 Trial Registration Date

2014-07-23

i Registration Status

Prospective

3 Secondary IDs

KW/FR-13-023(67-05)

4 Source(s) of Funding

SADS HONG KONG FOUNDATION

5 Primary Sponsor

Department of Medicine & Geriatrics, Princess Margaret Hospital

6 Secondary Sponsor

Pathology Department & Department of Paediatrics, Princess Margaret Hospital
Forensic Pathology Service, Department of Health

Function

Please specify

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

i Name

Dr. Ngai Shing MOK

ii Address

Princess Margaret Hospital, Lai Chi Kok, Kowloon, Hong Kong

iii Phone

(852) 64610145

iv Email

mokns@ha.org.hk

v Affiliation

Department of Medicines & Geriatrics, Princess Margaret Hospital

vi Country

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

i Name

Dr. Ngai Shing MOK

ii Address

Princess Margaret Hospital, Lai Chi Kook, Kowloon, Hong Kong

iii Phone

(852) 64610145

iv Email

mokns@ha.org.hk

v Affiliation

Department of Medicine & Geriatrics, Princess Margaret Hospital

vi Country

9 Official Scientific Title of the Study

Sudden Arrhythmia Death Syndromes in Young Victims of Sudden Cardiac Death in Hong Kong Identified by Clinical or Molecular Autopsy of Victims and Clinical Evaluation of Their First Degree Relatives (SADS-HK Study)

10 Public Title

Sudden Arrhythmia Death Syndromes in Young Victims of Sudden Cardiac Death in Hong Kong Identified by Clinical or Molecular Autopsy of Victims and Clinical Evaluation of Their First Degree Relatives (SADS-HK Study)

i Public Title in Chinese 研究名稱

突發心律失常死亡綜合症臨床檢驗及基因測試研究（SADS - HK研究）

11 Short Title (Optional)

SADS-HK Study

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?

2013-11-18

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Sudden Arrhythmia Death Syndromes

15 Intervention

i Types of intervention

Other

Please specify

Nil Intervention

ii Description/ name of Intervention/article

Not Applicable

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Not Applicable

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Not Applicable

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

Index SCD Victims
1. Age 5 to 40 years
2. Death 1 hour after onset of symptoms or within 24 hours of the victim being seen alive
3. Negative autopsy or autopsy shows evidence of either hypertrophic or arrhythmogenic right ventricular cardiomyopathy
4. Negative toxicological screening
5. Informed consent obtained from their next-of-kin for a molecular autopsy in the study

Relatives of index SCD Victim
 All first-degree relatives who consent to undergo the clinical and genetic evaluation as described in this study protocol

ii Exclusion Criteria

Index SCD Victim
1. SCD victim with genetically proven SADS

Relatives of index SCD Victim
1. Pregnant women
2. Mentally or cognitively disabled to give informed consent
3. Unable to attend assessment clinic or clinical evaluation in PMH
4. < 5 years old

iii Age Minimum

5 years old

iv Age Maximum

40 years (SD vicitims), no age limit for relatives

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

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-08-06

21 Target Sample Size

160

22 Recruitment Status

Unknown

23 Primary Outcome

Prevalence and types of SADS among the young SCD families in the study population identified by clinical and molecular autopsy of SCD victims and/ clinical and targeted genetic evaluation of their first-degree relatives

24 Secondary Outcome

1. Genotypes of SADS victims in the study population
2. Number of young SUD families identified with SADS by molecular autopsy
3. Number of young SUD families identified with SADS by clinical evaluation of first-degree relatives
4. Number of young SUD families identified with SADS by a combined approach
5. Pattern of inheritance of SADS and their clinical characteristics among young SUD familie

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-24

27 Primary Registry and Trial Identifying Number

ChiCTR-OCS-14005008

28 Date of Registration in Primary Registry

2014-07-25

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

www.sadshk.org

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Trial History Detail on 2015-08-24