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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Özlem Yıldırımtürk, Professor
  • Phone Number: 4020 00902122244950
  • Email: ozlemyt@gmail.com

Study Locations

  • Turkey
      • Istanbul, Turkey, 34381
        • Recruiting
        • Florence Nightinngale Hospital
        • Contact:
        • 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:
        • Sub-Investigator:
          • Özlem Yıldırımtürk, MD
        • Principal Investigator:
          • Saide Aytekin, Professor
        • Sub-Investigator:
          • Aylin Tuğcu, MD
        • Sub-Investigator:
          • Yelda Tayyareci, MD
        • Sub-Investigator:
          • Onur Levent Ulusoy, MD
        • Sub-Investigator:
          • Cihan Duran, MD
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florence Nightingale Hospital, Istanbul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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