Mitral Valve RegurgitationNCT01063322
New Techniques to Evaluate Mitral Regurgitation
An observational study of Mitral Valve Regurgitation, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial summary
Background: Mitral regurgitation, or leaking of the mitral heart valve, is usually studied and assessed with an ultrasound test called a two-dimensional (2D) echocardiogram. While this test has proved very useful, technological improvements have helped researchers develop ways to study the heart valves using imaging… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2010to 11 Apr 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, age greater than or equal to 21 years
- Able to give written informed consent
- Prior cardiac testing clinically read as having greater than mild MR
Who cannot join
- Atrial fibrillation or other irregular rhythm that would preclude adequate 3D image acquisition
- History of valve surgery or significant valve disease other than mitral regurgitation
- Patients with pacemakers, defibrillators, cerebral aneurysm clips, neural stimulators, ear implants or other clinical contra-indications for magnetic resonance scanning will be excluded from the CMR portion of the study
- Any unstable condition that would make additional imaging time inadvisable (in the opinion of the investigator or managing physician)
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Mitral regurgitation, or leaking of the mitral heart valve, is usually studied and assessed with an ultrasound test called a two-dimensional (2D) echocardiogram. While this test has proved very useful, technological improvements have helped researchers develop ways to study the heart valves using imaging with three-dimensional (3D) capabilities. In addition, recently developed magnetic resonance imaging (MRI) techniques may be able to provide better information about the causes and severity of the leak. Researchers are interested in testing these new techniques to determine their usefulness for patients with mitral regurgitation.
Read more
Objectives:
- To evaluate newer methods of studying mitral regurgitation severity using real-time 3D echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMRI).
Eligibility:
- Individuals at least 21 years of age who have been diagnosed with more than mild mitral regurgitation.
Design:
- Participants will have two procedures as part of this study: an echocardiogram and an MRI scan.
- For the echocardiogram, participants will have an ultrasound scan with a special kind of probe. Participants may also receive an injection of a contrast agent to provide a better image of the heart on the scan. The scan will take approximately 1 hour to complete.
- For the MRI scan, participants will have a standard MRI with special pads placed on the chest to provide better imaging of the heart. The scan will usually take between 45 and 90 minutes to complete.
Read the detailed description
Echocardiography is currently the technique of choice to assess the etiology and severity of mitral regurgitation (MR). Multiple 2D and Doppler parameters are assessed in an integrated fashion and the proximal flow convergent zone of the mitral regurgitation jet is used to calculate effective regurgitant orifice area and regurgitant volume. These measurements have been shown to have important prognostic information. In the last two years, the development of transesophageal imaging with 3D capability has allowed a better visualization of mitral leaflet pathology. Color Doppler 3D studies have shown that 2D methods generally underestimate mitral regurgitant volume. Magnetic resonance techniques have recently been developed to quantitate flow and calculate regurgitant volumes.
The purpose of this study is to evaluate newer methods of quantitating mitral regurgitation severity using real-time 3D echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMR). Although RT3DE measurements have been shown to correlate well with CMR measures of LV volumes, using a 3D volumetric method to calculate mitral regurgitant volumes has not been well studied. In patients with more than mild mitral regurgitation, we will obtain transthoracic RT3DE measures of mitral regurgitant volume and compare them with traditional 2D measures of MR severity. We will also compare RT3DE and CMR measures of mitral regurgitant volume.
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral Regurgitation, Echocardiography, Cardiac Magnetic Resonance, Regurgitant Volume, Mitral Valve Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study start1 Feb 2010
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vandana Sachdev, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063322
- Sponsor's protocol ID
- 100039
- Other IDs
- 10-H-0039
- Status last verified
- 11 Apr 2018
- First submitted
- 4 Feb 2010
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Sheikh K, Smith SW, von Ramm O, Kisslo J. Real-time, three-dimensional echocardiography: feasibility and initial use. Echocardiography. 1991 Jan;8(1):119-25. doi: 10.1111/j.1540-8175.1991.tb01409.x.
PubMed 10149247Schmidt MA, Ohazama CJ, Agyeman KO, Freidlin RZ, Jones M, Laurienzo JM, Brenneman CL, Arai AE, von Ramm OT, Panza JA. Real-time three-dimensional echocardiography for measurement of left ventricular volumes. Am J Cardiol. 1999 Dec 15;84(12):1434-9. doi: 10.1016/s0002-9149(99)00591-3.
PubMed 10606118Jacobs LD, Salgo IS, Goonewardena S, Weinert L, Coon P, Bardo D, Gerard O, Allain P, Zamorano JL, de Isla LP, Mor-Avi V, Lang RM. Rapid online quantification of left ventricular volume from real-time three-dimensional echocardiographic data. Eur Heart J. 2006 Feb;27(4):460-8. doi: 10.1093/eurheartj/ehi666. Epub 2005 Nov 30.
PubMed 16319085
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Techniques to Evaluate Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT01063322
- Acronym / sponsor ID
- 100039
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral Regurgitation, Echocardiography, Cardiac Magnetic Resonance, Regurgitant Volume, Mitral Valve Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 1 Feb 2010
- Study completion
- 11 Apr 2018
- First posted
- 5 Feb 2010 (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.
Background:
- Mitral regurgitation, or leaking of the mitral heart valve, is usually studied and assessed with an ultrasound test called a two-dimensional (2D) echocardiogram. While this test has proved very useful, technological improvements have helped researchers develop ways to study the heart valves using imaging with three-dimensional (3D) capabilities. In addition, recently developed magnetic resonance imaging (MRI) techniques may be able to provide better information about the causes and severity of the leak. Researchers are interested in testing these new techniques to determine their usefulness for patients with mitral regurgitation.
Objectives:
- To evaluate newer methods of studying mitral regurgitation severity using real-time 3D echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMRI).
Eligibility:
- Individuals at least 21 years of age who have been diagnosed with more than mild mitral regurgitation.
Design:
- Participants will have two procedures as part of this study: an echocardiogram and an MRI scan.
- For the echocardiogram, participants will have an ultrasound scan with a special kind of probe. Participants may also receive an injection of a contrast agent to provide a better image of the heart on the scan. The scan will take approximately 1 hour to complete.
- For the MRI scan, participants will have a standard MRI with special pads placed on the chest to provide better imaging of the heart. The scan will usually take between 45 and 90 minutes to complete.
Detailed description
Echocardiography is currently the technique of choice to assess the etiology and severity of mitral regurgitation (MR). Multiple 2D and Doppler parameters are assessed in an integrated fashion and the proximal flow convergent zone of the mitral regurgitation jet is used to calculate effective regurgitant orifice area and regurgitant volume. These measurements have been shown to have important prognostic information. In the last two years, the development of transesophageal imaging with 3D capability has allowed a better visualization of mitral leaflet pathology. Color Doppler 3D studies have shown that 2D methods generally underestimate mitral regurgitant volume. Magnetic resonance techniques have recently been developed to quantitate flow and calculate regurgitant volumes.
The purpose of this study is to evaluate newer methods of quantitating mitral regurgitation severity using real-time 3D echocardiography (RT3DE) and cardiac magnetic resonance imaging (CMR). Although RT3DE measurements have been shown to correlate well with CMR measures of LV volumes, using a 3D volumetric method to calculate mitral regurgitant volumes has not been well studied. In patients with more than mild mitral regurgitation, we will obtain transthoracic RT3DE measures of mitral regurgitant volume and compare them with traditional 2D measures of MR severity. We will also compare RT3DE and CMR measures of mitral regurgitant volume.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient, age greater than or equal to 21 years
- Able to give written informed consent
- Prior cardiac testing clinically read as having greater than mild MR
Key exclusion criteria (5 listed)
- Atrial fibrillation or other irregular rhythm that would preclude adequate 3D image acquisition
- History of valve surgery or significant valve disease other than mitral regurgitation
- Patients with pacemakers, defibrillators, cerebral aneurysm clips, neural stimulators, ear implants or other clinical contra-indications for magnetic resonance scanning will be excluded from the CMR portion of the study
- Any unstable condition that would make additional imaging time inadvisable (in the opinion of the investigator or managing physician)
- Pregnant or lactating women
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 10149247Sheikh K, Smith SW, von Ramm O, Kisslo J. Real-time, three-dimensional echocardiography: feasibility and initial use. Echocardiography. 1991 Jan;8(1):119-25. doi: 10.1111/j.1540-8175.1991.tb01409.x.
- Background: PubMed 10606118Schmidt MA, Ohazama CJ, Agyeman KO, Freidlin RZ, Jones M, Laurienzo JM, Brenneman CL, Arai AE, von Ramm OT, Panza JA. Real-time three-dimensional echocardiography for measurement of left ventricular volumes. Am J Cardiol. 1999 Dec 15;84(12):1434-9. doi: 10.1016/s0002-9149(99)00591-3.
- Background: PubMed 16319085Jacobs LD, Salgo IS, Goonewardena S, Weinert L, Coon P, Bardo D, Gerard O, Allain P, Zamorano JL, de Isla LP, Mor-Avi V, Lang RM. Rapid online quantification of left ventricular volume from real-time three-dimensional echocardiographic data. Eur Heart J. 2006 Feb;27(4):460-8. doi: 10.1093/eurheartj/ehi666. Epub 2005 Nov 30.
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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.
Vandana Sachdev, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 Regurgitation, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Dec 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01063322, which also lists 3 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 17 Dec 2019.