Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00372

2 Trial Registration Date

2013-06-14

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

N/A

5 Primary Sponsor

Pending research grants council(RGC)grant approved.

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

2632 1752

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, Clinical Science Building Prince of Wales Hospital, Shatin,Hong Kong.

iii Phone

26321299

iv Email

alexpwlee@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

A Study on interactive dynamics of the mitral complex: New Physiologic Insights with Real-time 3-Dimensional Echocardiography

10 Public Title

A Study on interactive dynamics of the mitral complex: New Physiologic Insights with Real-time 3-Dimensional Echocardiography

i Public Title in Chinese 研究名稱

通過實時三維超聲心動圖研究二尖瓣複合體的生理

11 Short Title (Optional)

Interactive dynamics of the mitral valve complex

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?

2013-03-21

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

This study has 3 parts. part 1 study population:Subjects(age>_18y)referred for clinically indicated transesophageal echocardiography(e.g exclusion of endocarditis, cardio-embolism,patent foramen ovale,,etc)and found to have no underlying structural cardiac disease or arrhythmia will be included. part 2 study population:consecutive patients with MVP or IMR referred for clinically indicated preoperative transesophageal echocardiography for surgical repair will be prospectively enrolled. part 3 study population:All subjects in part 2 who undergo clinically indicated mitral valve surgery(repair or replacement) will be prospectively enrolled into part3.

ii Exclusion Criteria

Part 1:Any evidence on echocardiography of structural cardiac disease, depressed ejection fraction(<50%),prior history of cardiac surgery, revascularization,revascularization, rheumatic valve disease,or endocarditis;contraindication to transesophageal echocardiography.Part2:AV disease, tricuspid regurgitation more than mild, or pericardial or congenital heart disease;history of MV surgery; endocarditis;in atrial fibrillation at the time of image acquisition.Part 3:Same as Part 2.

iii Age Minimum

18

iv Age Maximum

N/A

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

2014-01-01

21 Target Sample Size

200

22 Recruitment Status

Unknown

23 Primary Outcome

Mitral valve 3D geometry and dynamics

24 Secondary Outcome

A detail clinical history and physical exam (including NYHA class, medication history ,body weight, height,bloodpressure,heart rate ,and cardiac exam)
SF-36
ECG

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-26

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-13003273

28 Date of Registration in Primary Registry

Back History

Trial Detail