NCT00654472

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 8, 2008

Status Verified

April 1, 2008

Enrollment Period

2 months

First QC Date

April 2, 2008

Last Update Submit

April 7, 2008

Conditions

Mitral Valve Stenosis

Keywords

magnetic resonance imaging, mitral valve area

Study Arms (2)

A

Mitral valve area above 1.5 cm2

B

Mitral valve area 1.5 cm2 and below 1.5 cm2

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

tertiary care clinic

You may qualify if:

  • rheumatic mitral valve stenosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florence Nightinngale Hospital

Istanbul, 34381, Turkey (Türkiye)

RECRUITING

TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

Istanbul, 34381, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15234421BACKGROUND

  • 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.

    PMID: 15963408BACKGROUND

MeSH Terms

Conditions

Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Saide Aytekin, Professor

    T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

    STUDY DIRECTOR

Central Study Contacts

Saide Aytekin, Professor

CONTACT

00902122244950saideaytekin@gmail.com

Özlem Yıldırımtürk, Professor

CONTACT

00902122244950ozlemyt@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 8, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 8, 2008

Record last verified: 2008-04

Locations

TU(2)