Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00405

2 Trial Registration Date

2014-04-11

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Division of Cardiology

5 Primary Sponsor

Division of Cardiology

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Xue Ting WANG

ii Address

Heart center 10/F, Department of medicine and Therapeutics,Clinical Science Building Prince of Wales Hospital,Shatin,Hong Kong

iii Phone

26321752

iv Email

xueting@cuhk.edu.hk

v Affiliation

CUHK

vi Country

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

i Name

Prof.Alex Pui Wai LEE

ii Address

9/F,Department of medicine and Therapeutics,Chinical Science Building Prince of Wales Hospital,Shatin,Hong Kong

iii Phone

2632 1299

iv Email

alexpwlee@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

Mechanism of Recurrence/Persistence of Mitral Regurgitation After Mitral Valve Repair: A Retrospective Echocardiographic Study

10 Public Title

Mechanism of Recurrence/Persistence of Mitral Regurgitation After Mitral Valve Repair: A Retrospective Echocardiographic Study

i Public Title in Chinese 研究名稱

N/A

11 Short Title (Optional)

MR recurrence/persistence after mitral valve repair

12 Countries of Recruitment

Hong Kong CHINA

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-03-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Mitral regurgitation

15 Intervention

i Types of intervention

Other

Please specify

N/A

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

N/A

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

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

Patients who underwent clinically indicated mitral valve surgery in the Prince of Wales Hospital from January 2008 to January 2014, either as a lone procedure or associated with other cardiac procedures.

ii Exclusion Criteria

1. Patients who did not have a record of preoperative echocardiography available at our institution (e.g. performed elsewhere, no stored images, etc).
2. Patients who lost to clinical follow up.

iii Age Minimum

18

iv Age Maximum

89

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Historical control

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-05-01

21 Target Sample Size

150

22 Recruitment Status

Unknown

23 Primary Outcome

2D and 3D geometry of the mitral valve
Degree of MR
Re-operation
Death

24 Secondary Outcome

Age, sex, body weight and height
NYHA functional class
Blood pressure and heart rate
Operative findings and procedures

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-05-13

27 Primary Registry and Trial Identifying Number

ChiCTR-OCS-14004506

28 Date of Registration in Primary Registry

2014-04-14

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-05-13