Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00406

2 Trial Registration Date

2014-04-11

i Registration Status

Prospective

3 Secondary IDs

CRE-2014.108

4 Source(s) of Funding

Pending RGC grant approval

5 Primary Sponsor

Division of Cardiology
Department of Medicine and Therapeutics
The Chinese University of Hong Kong

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,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

Dynamic quantification of ventriculo-annular motion with real-time 3D transesophageal echocardiography in mitral valve prolapse: Is systolic annular deepening important for the pathogenesis of mitral regurgitation?

10 Public Title

Dynamic quantification of ventriculo-annular motion with real-time 3D transesophageal echocardiography in mitral valve prolapse: Is systolic annular deepening important for the pathogenesis of mitral regurgitation?

i Public Title in Chinese 研究名稱

實時三維經食道超聲二尖瓣脫垂的動態定量：瓣環鞍形深化是否二尖瓣關閉不全的重要發病機制？

11 Short Title (Optional)

Mitral annulus dynamics 3D echo study

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

1. MVP which is defined echocardiographically as more than 2mm displacement of the mitral leaflets into the left atrium beyond the annulus plane in parasternal long-axis view during systole, and
2. Clinical indication for TEE including evaluation of regurgitation severity, assessment of mitral valve repairability, preoperative evaluation, non-diagnostic transthoracic images, exclusion of endocarditis, and evaluation of cardiac source of embolic event.
- The proximal isovelocity surface area method will be used to quantify the effective regurgitant orifice (ERO) (32), with flow constraint corrected for the angle with the adjacent walls in cases where the regurgitation convergence is eccentric. Patients will be divided into 2 groups according to MR severity. The MVP-MR+ group with MR ≥3+ (ERO ≥0.3cm^2) and the MVP-MR- group with MR≤2+ (ERO ≤0.29 cm^2). Ruptured chordae tendinae and flail leaflet will be diagnosed by combined information obtained by 2D/3D echocardiography as previously described (16).
- Normal reference group: Patients who are referred for TEE and found to have no underlying cardiac abnormality or rhythm disturbance will be recruited.
- Non-prolapse organic MR group: Patients who have moderate or severe organic MR due to non-prolapse pathology as a reference group to ascertain any abnormality in ventriculo-annular interaction is not secondary to MR per se.

ii Exclusion Criteria

Mitral stenosis
-Aortic valve disease
-Congenital or pericardial diseases
-Endocarditis
-Cardiomyopathy
-Pregnancy
-Age<18y
-Contraindications to TEE

iii Age Minimum

18

iv Age Maximum

999

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

2015-01-01

21 Target Sample Size

150

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Early systolic rate of change of MA geometry
Single time point at clinical TEE examination

24 Secondary Outcome

N/A

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-TRC-14004749

28 Date of Registration in Primary Registry

2014-06-05

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-06-16