- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654472
Mitral Valve Area Assessment: Comparison With Transthoracic Echocardiography and Magnetic Resonance Imaging
April 7, 2008 updated by: Florence Nightingale Hospital, Istanbul
Quantification of Rheumatic Mitral Stenosis With Cardiac Magnetic Resonance Imaging and Comparison With Transthoracic Echocardiography
To compare mitral valve area in rheumatic mitral valve stenosis with cardiac magnetic resonance imaging and conventional transthoracic echocardiography.
Study Overview
Status
Unknown
Conditions
Detailed 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
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Saide Aytekin, Professor
- Phone Number: 4038 00902122244950
- Email: saideaytekin@gmail.com
Study Contact Backup
- Name: Özlem Yıldırımtürk, Professor
- Phone Number: 4020 00902122244950
- Email: ozlemyt@gmail.com
Study Locations
-
-
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Istanbul, Turkey, 34381
- Recruiting
- Florence Nightinngale Hospital
-
Contact:
- Saide Ayetkin, Professor
- Phone Number: 4038 00902122244950
- Email: saideaytekin@gmail.com
-
Contact:
- Özlem Yıldırımtürk, MD
- Phone Number: 4020 00902122244950
- Email: ozlemyt@gmail.com
-
Istanbul, Turkey, 34381
- Recruiting
- TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
-
Contact:
- Saide Aytekin, Professor
- Phone Number: 4038 00902122244950
- Email: saideaytekin@gmail.com
-
Sub-Investigator:
- Özlem Yıldırımtürk, MD
-
Principal Investigator:
- Saide Aytekin, Professor
-
Sub-Investigator:
- Aylin Tuğcu, MD
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Sub-Investigator:
- Yelda Tayyareci, MD
-
Sub-Investigator:
- Onur Levent Ulusoy, MD
-
Sub-Investigator:
- Cihan Duran, MD
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Sub-Investigator:
- Mustafa Şirvancı, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
tertiary care clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
A
Mitral valve area above 1.5 cm2
|
B
Mitral valve area 1.5 cm2 and below 1.5 cm2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Saide Aytekin, Professor, T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1016/j.jacc.2004.03.038.
- 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. doi: 10.1016/j.jacc.2005.03.036.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Anticipated)
June 1, 2008
Study Completion (Anticipated)
June 1, 2008
Study Registration Dates
First Submitted
April 2, 2008
First Submitted That Met QC Criteria
April 7, 2008
First Posted (Estimate)
April 8, 2008
Study Record Updates
Last Update Posted (Estimate)
April 8, 2008
Last Update Submitted That Met QC Criteria
April 7, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OY1975
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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