Mitral Valve StenosisNCT00654472
Mitral Valve Area Assessment: Comparison With Transthoracic Echocardiography and Magnetic Resonance Imaging
An observational study of Mitral Valve Stenosis, run by Florence Nightingale Hospital, Istanbul at 2 sites in Turkey (Türkiye).
Trial summary
To compare mitral valve area in rheumatic mitral valve stenosis with cardiac magnetic resonance imaging and conventional transthoracic echocardiography. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Mitral Valve Stenosis
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Apr 2008to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary care clinic
Who may be able to join
- rheumatic mitral valve stenosis
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Florence Nightinngale Hospital
Istanbul, 34381
Saide Ayetkin, Professor, 00902122244950 ext. 4038, saideaytekin@gmail.com
Özlem Yıldırımtürk, MD, 00902122244950 ext. 4020, ozlemyt@gmail.com
- Recruiting
TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
Istanbul, 34381
Saide Aytekin, Professor, 00902122244950 ext. 4038, saideaytekin@gmail.com
Özlem Yıldırımtürk, MD
About this study
Official title: 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.
Read the 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
- Conditions
- Mitral Valve Stenosis
- Keywords
- magnetic resonance imaging, mitral valve area
- Medical subject headings
- Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Mitral valve area above 1.5 cm2 | |
| B | Mitral valve area 1.5 cm2 and below 1.5 cm2 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florence Nightingale Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Saide Aytekin, Professor, Study director, T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654472
- Sponsor's protocol ID
- OY1975
- Status last verified
- Apr 2008
- First submitted
- 2 Apr 2008
- Last updated
- 8 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15234421Djavidani 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.
PubMed 15963408
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Rheumatic Mitral Stenosis With Cardiac Magnetic Resonance Imaging and Comparison With Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT00654472
- Acronym / sponsor ID
- OY1975
- Conditions
- Mitral Valve Stenosis
- Keywords
- magnetic resonance imaging, mitral valve area
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Florence Nightingale Hospital, IstanbulUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare mitral valve area in rheumatic mitral valve stenosis with cardiac magnetic resonance imaging and conventional transthoracic echocardiography.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Mitral valve area above 1.5 cm2 |
| B | – | –Mitral valve area 1.5 cm2 and below 1.5 cm2 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic
Key inclusion criteria (1 listed)
- rheumatic mitral valve stenosis
Key exclusion criteria (7 listed)
- Degenerative mitral valve disease
- EF<50%
- atrial fibrillation
- inconclusive planimetric assessment
- moderate or severe mitral regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2008.
- Background: PubMed 15234421Lin 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.
- Background: PubMed 15963408Djavidani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saide Aytekin, Professor study director
T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Stenosis, run by Florence Nightingale Hospital, Istanbul at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saide Aytekin, Professor (00902122244950 ext. 4038, saideaytekin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00654472, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2008.