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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00654472
Other study ID # OY1975
Secondary ID
Status Recruiting
Phase N/A
First received April 2, 2008
Last updated April 7, 2008
Start date April 2008
Est. completion date June 2008

Study information

Verified date April 2008
Source Florence Nightingale Hospital, Istanbul
Contact Saide Aytekin, Professor
Phone 00902122244950
Email saideaytekin@gmail.com
Is FDA regulated No
Health authority Turkey:Ministry of Health; Turkey: Ethics Commitee
Study type Observational

Clinical Trial Summary

To compare mitral valve area in rheumatic mitral valve stenosis with cardiac magnetic resonance imaging and conventional transthoracic echocardiography.


Description:

Clinical assessment of severity of mitral stenosis depends on both the presence of symptoms and mitral valve area . Evaluation of mitral valve area with transthoracic echocardiography maintains rapid, accurate analysis of valve disease and serves as a practical gold standard for clinical evaluation. Cardiac magnetic resonance imaging (CMRI) is a recently used method that allows to evaluate cardiac structures and function noninvasively. Direct visualization of valve area with CMRI is also possible and it has been shown that the valve area assessed by CMRI planimetry correlates reliably with the invasive assessment. Velocity-encoded cardiac magnetic resonance imaging can be used to quantify mitral valve area. The objective of this study was to evaluate mitral valve area with CMRI and compare it with echocardiographic methods including 2D planimetry, Doppler continuation equation and Doppler pressure half-time


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- rheumatic mitral valve stenosis

Exclusion Criteria:

- Degenerative mitral valve disease

- EF<50%

- atrial fibrillation

- inconclusive planimetric assessment

- moderate or severe mitral regurgitation

- moderate or severe aortic regurgitation

- history of previous mitral valve commissurotomy or balloon valvotomy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Florence Nightinngale Hospital Istanbul
Turkey TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Florence Nightingale Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Djavidani B, Debl K, Lenhart M, Seitz J, Paetzel C, Schmid FX, Nitz WR, Feuerbach S, Riegger G, Luchner A. Planimetry of mitral valve stenosis by magnetic resonance imaging. J Am Coll Cardiol. 2005 Jun 21;45(12):2048-53. — View Citation

Lin SJ, Brown PA, Watkins MP, Williams TA, Lehr KA, Liu W, Lanza GM, Wickline SA, Caruthers SD. Quantification of stenotic mitral valve area with magnetic resonance imaging and comparison with Doppler ultrasound. J Am Coll Cardiol. 2004 Jul 7;44(1):133-7. — View Citation

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