Tricuspid Valve Regurgitation, Non-rheumaticNCT01504880
Atrioventricular Valve Regurgitation Vena Contracta; Echo Versus MRI
An observational study of Tricuspid Valve Regurgitation, Non-rheumatic and Mitral Valve Regurgitation, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic resonance imaging (CMR) as the non-invasive "gold standard" compared to transthoracic echocardiography (TTE) to evaluate measurements of the width… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tricuspid Valve Regurgitation, Non-rheumatic, Mitral Valve Regurgitation
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to 19 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled for clinically indicated MRI and have had an echocardiogram in the last 6 months with AV Valve (AVV) Insufficiency.
Who may be able to join
- Audible AV valve regurgitation on clinical exam, as noted by most recent clinic note.
- Clinically indicated CMR study scheduled and have had an echocardiogram in the last 6 months
Who cannot join
- Poor quality CMR study
- Unable to complete a CMR
- Have a contraindication to CMR scan (e.g., pregnancy, pacemaker or defibrillator presence, unable to hold still within scanner for imaging)
- Common AV valve
- Corresponding semilunar valve regurgitation which precludes use of stroke volume comparison as a second means of assessing AVV regurgitation by CMR
- Intracardiac shunts which precludes use of stroke volume comparison as a second means of assessing AVV regurgitation by CMR.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Evaluation of Mitral and Tricuspid Regurgitation: Cardiovascular Magnetic Resonance Imaging Versus Echocardiographic Doppler Color Flow Mapping of the Vena Contracta
The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic resonance imaging (CMR) as the non-invasive "gold standard" compared to transthoracic echocardiography (TTE) to evaluate measurements of the width of the regurgitation jet (vena contracta (VC)) to demonstrate the utility of the VC as a means to objectively evaluate atrioventricular valve regurgitation. In addition, feasibility and other quantitative and qualitative measures of regurgitation will be compared between CMR and TTE.
- Hypothesis 1: The ability to objectively evaluate atrioventricular valve regurgitation and VC width with TTE and CMR has a high feasibility rate with acceptable intra and inter-observer variability by two independent readers.
- Hypothesis 2: There will be positive correlation between the TTE measurement of the VC width and quantitative assessment of atrioventricular valve regurgitation by TTE and CMR.
- Hypothesis 3: There will be a positive correlation between the quantitative measurements of atrioventricular valve regurgitation by phase contrast velocity encoded CMR with quantitative values as measured by TTE.
- Hypothesis 4: There will be a positive correlation between qualitative assessment of atrioventricular valve regurgitation by CMR compared to TTE.
Read the detailed description
BACKGROUND, SIGNIFICANCE, AND RATIONALE (including preliminary studies and any results) The integrity of the two atrioventricular valves (AVV)(i.e., the mitral and tricuspid valve) plays an important role in the evaluation and management of patients with congenital and acquired heart disease. Loss of valve integrity (i.e., valve leakage in the reverse direction of normal blood flow), is known as valve regurgitation. Increasing severity of mitral regurgitation has been associated with increased mortality and morbidity. Tricuspid regurgitation can be a progressive problem that results in right atrial and ventricular dilation and possible right heart failure. Similarly, mitral valve regurgitation can result in left atrial and left ventricular enlargement. Treatment options for valvular regurgitation are based upon the degree of regurgitation in both adults and children. Therefore, assessment of the degree of AV valvular regurgitation has important clinical ramifications. AV valve regurgitation can be assessed in several ways, including both invasive and noninvasive modalities. The invasive assessment is performed by cardiac catheterization which enables qualitative and quantitative measurements of AV valve regurgitation and in the past has been considered the "gold standard". Noninvasive assessment is still the preferred method and consists of echocardiography, electrocardiography, chest x-ray, and CMR. TTE can be used qualitatively to describe the amount of AV valve regurgitation by the degree of color flow Doppler reflux into the left atrium during left ventricular contraction. This approach grades the regurgitation as mild, moderate or severe similar to angiographic grading systems, but is relatively subjective and affected by technical factors. TTE can quantitatively evaluate AV valve regurgitation through calculation of regurgitation orifice area, regurgitation volume and regurgitation fraction. These methods have been shown to have a good correlation when used for mitral valves compared to cardiac catheterization and CMR in adults. However, quantitative techniques are time consuming and require multiple measurements and more complex calculations. A simpler technique of objectively characterizing the regurgitation of the AV valves by TTE is measuring the width of the vena contracta (VC). The VC is the narrowest portion of a regurgitant jet which occurs at the level of or just below the valve leaflets and represents the effective regurgitant orifice. In adult studies, this method has shown that increase in VC width of the mitral valve strongly correlates with qualitative angiographic grades and quantitative measurements of regurgitant volume by cardiac catheterization and is a better assessment of regurgitation than measuring the regurgitant jet by TTE. Changes in VC width also had strong correlation with quantitative measurements of regurgitant volume and regurgitant orifice area using TTE. It is our intent to evaluate the feasibility and correlation of measurements of AV valve regurgitation by TTE with focus on the VC in pediatric patients compared to the non-invasive "gold standard" measurements by CMR.
- Keywords
- Mitral Regurgitation, Tricuspid Regurgitation, Vena Contracta
- Medical subject headings
- Tricuspid Valve Insufficiency, Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Vena Contracta Value
Comparison of the echocardiographic measured vena contracta with quantitative value of mitral or tricuspid regurgitation as measured by MRI.
Measured: At time of Echo and MRI
Secondary outcomes (1)
Mitral and Tricuspid Regurgitation Fraction
Quantitative echo measurements of mitral or tricuspid valve regurgitation fraction will be correlated to MRI derived regurgitation fraction of the mitral or tricuspid valves.
Measured: At time of Echo and MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJun 2010
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve Regurgitation, Non-rheumaticStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Benjamin Goot, Medical College of Wisconsin
- Investigators
- Benjamin Goot, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504880
- Sponsor's protocol ID
- CHW 09/155
- Other IDs
- GC 960
- Status last verified
- Feb 2020
- First submitted
- 3 Jan 2012
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mitral and Tricuspid Regurgitation: Cardiovascular Magnetic Resonance Imaging Versus Echocardiographic Doppler Color Flow Mapping of the Vena Contracta
- ClinicalTrials.gov ID
- NCT01504880
- Acronym / sponsor ID
- CHW 09/155
- Keywords
- Mitral Regurgitation, Tricuspid Regurgitation, Vena Contracta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Jun 2010
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 6 Jan 2012 (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.
The purpose of this pilot study is to evaluate mitral (left atrioventricular valve) and tricuspid (right atrioventricular valve (AVV)) regurgitation using cardiac magnetic resonance imaging (CMR) as the non-invasive "gold standard" compared to transthoracic echocardiography (TTE) to evaluate measurements of the width of the regurgitation jet (vena contracta (VC)) to demonstrate the utility of the VC as a means to objectively evaluate atrioventricular valve regurgitation. In addition, feasibility and other quantitative and qualitative measures of regurgitation will be compared between CMR and TTE.
- Hypothesis 1: The ability to objectively evaluate atrioventricular valve regurgitation and VC width with TTE and CMR has a high feasibility rate with acceptable intra and inter-observer variability by two independent readers.
- Hypothesis 2: There will be positive correlation between the TTE measurement of the VC width and quantitative assessment of atrioventricular valve regurgitation by TTE and CMR.
- Hypothesis 3: There will be a positive correlation between the quantitative measurements of atrioventricular valve regurgitation by phase contrast velocity encoded CMR with quantitative values as measured by TTE.
- Hypothesis 4: There will be a positive correlation between qualitative assessment of atrioventricular valve regurgitation by CMR compared to TTE.
Detailed description
BACKGROUND, SIGNIFICANCE, AND RATIONALE (including preliminary studies and any results) The integrity of the two atrioventricular valves (AVV)(i.e., the mitral and tricuspid valve) plays an important role in the evaluation and management of patients with congenital and acquired heart disease. Loss of valve integrity (i.e., valve leakage in the reverse direction of normal blood flow), is known as valve regurgitation. Increasing severity of mitral regurgitation has been associated with increased mortality and morbidity. Tricuspid regurgitation can be a progressive problem that results in right atrial and ventricular dilation and possible right heart failure. Similarly, mitral valve regurgitation can result in left atrial and left ventricular enlargement. Treatment options for valvular regurgitation are based upon the degree of regurgitation in both adults and children. Therefore, assessment of the degree of AV valvular regurgitation has important clinical ramifications. AV valve regurgitation can be assessed in several ways, including both invasive and noninvasive modalities. The invasive assessment is performed by cardiac catheterization which enables qualitative and quantitative measurements of AV valve regurgitation and in the past has been considered the "gold standard". Noninvasive assessment is still the preferred method and consists of echocardiography, electrocardiography, chest x-ray, and CMR. TTE can be used qualitatively to describe the amount of AV valve regurgitation by the degree of color flow Doppler reflux into the left atrium during left ventricular contraction. This approach grades the regurgitation as mild, moderate or severe similar to angiographic grading systems, but is relatively subjective and affected by technical factors. TTE can quantitatively evaluate AV valve regurgitation through calculation of regurgitation orifice area, regurgitation volume and regurgitation fraction. These methods have been shown to have a good correlation when used for mitral valves compared to cardiac catheterization and CMR in adults. However, quantitative techniques are time consuming and require multiple measurements and more complex calculations. A simpler technique of objectively characterizing the regurgitation of the AV valves by TTE is measuring the width of the vena contracta (VC). The VC is the narrowest portion of a regurgitant jet which occurs at the level of or just below the valve leaflets and represents the effective regurgitant orifice. In adult studies, this method has shown that increase in VC width of the mitral valve strongly correlates with qualitative angiographic grades and quantitative measurements of regurgitant volume by cardiac catheterization and is a better assessment of regurgitation than measuring the regurgitant jet by TTE. Changes in VC width also had strong correlation with quantitative measurements of regurgitant volume and regurgitant orifice area using TTE. It is our intent to evaluate the feasibility and correlation of measurements of AV valve regurgitation by TTE with focus on the VC in pediatric patients compared to the non-invasive "gold standard" measurements by CMR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled for clinically indicated MRI and have had an echocardiogram in the last 6 months with AV Valve (AVV) Insufficiency.
Key inclusion criteria (2 listed)
- Audible AV valve regurgitation on clinical exam, as noted by most recent clinic note.
- Clinically indicated CMR study scheduled and have had an echocardiogram in the last 6 months
Key exclusion criteria (6 listed)
- Poor quality CMR study
- Unable to complete a CMR
- Have a contraindication to CMR scan (e.g., pregnancy, pacemaker or defibrillator presence, unable to hold still within scanner for imaging)
- Common AV valve
- Corresponding semilunar valve regurgitation which precludes use of stroke volume comparison as a second means of assessing AVV regurgitation by CMR
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
Vena Contracta Value
Time frame: At time of Echo and MRI
Comparison of the echocardiographic measured vena contracta with quantitative value of mitral or tricuspid regurgitation as measured by MRI.
1 secondary outcome
Mitral and Tricuspid Regurgitation Fraction
Time frame: At time of Echo and MRI
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 6 Feb 2020.
- Individual participant dataSharing planned: Yes
Related trials for Tricuspid Valve Regurgitation, Non-rheumatic
RecruitingObservational study
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Cardiac Pacing, Artificial, Tricuspid Valve Regurgitation, Non-rheumatic
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.
Benjamin Goot, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Valve Regurgitation, Non-rheumatic and Mitral Valve Regurgitation, run by Medical College of Wisconsin at 1 site 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 2 inclusion and 6 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 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Vena Contracta Value (time frame: At time of Echo and MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2020.