Aortic RegurgitationSUBCLARNCT03549091
Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI
A study testing transthoracic echocardiography and Cardiovascular Magnetic Resonance Imaging in people with Aortic Regurgitation, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Aortic insufficiency (IA) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves. It represents about 10% of valvular pathologies but the annual mortality of nonoperated patients can be as high as 10% to 20%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation
- What is being tested?
- transthoracic echocardiography and Cardiovascular Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2018to 31 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient able to give informed consent to participate in the study
- Patient with transthoracic echocardiography and MRI prescription
Who cannot join
- Contraindication to MRI
- Pathologies of the thoracic aorta (aneurism, dissection, stenosis)
- Pathologies of the left subclavian artery (stenosis, narrowing)
- Persistent arterial canal
- Arteriovenous fistula of the upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI as an Indicator of Severe Aortic Regurgitation
Aortic insufficiency (IA) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves. It represents about 10% of valvular pathologies but the annual mortality of nonoperated patients can be as high as 10% to 20%. The quantification of AI is therefore important as it can remain perfectly asymptomatic for a long time.
Doppler echocardiography is currently the key examination to confirm the presence of valvulopathy, to allow positive diagnosis of valve leakage regardless of location, to specify the etiology and mechanism of regurgitation. The quantification of IA requires, in transthoracic ultrasound, to take into account many parameters that individually have all certain limitations. The recommendations are therefore to have an integrative approach considering a combination of different parameters and an overall interpretation. This makes it possible to evaluate with greater precision the importance of the leak. Thus, there is the difficulty of quantifying moderate and severe AI for lack of a truly unique criterion. One of the evaluation criteria commonly used in transthoracic ultrasound is diastolic regurgitation in the aortic arch but this assessment is sometimes difficult. The left subclavian artery (SCG) is more accessible than the aortic arch in terms of the ultrasound window. The measurements will be easier to record since the vessel is more superficial and there are fewer air interpositions than for the aortic arch. The quantification of the AI based on this new element will be compared to the other previously validated ultrasound criteria. The investigators will use this study to describe the feasibility of collecting coronary flow in the artery (IVA), and they will compare systolic velocity, diastolic rate / systolic rate ratio compared to a control group without severe aortic insufficiency (grades 2 and 3). The flows recorded in the IVA will be compared to the importance of the aortic leakage according to its different modes of quantification (ultrasound and MRI). The aim of the study will be to show that diastolic reflux in the left subclavian artery is a marker of severe AI (grades 2 and 3) by comparing this regurgitation with that measured at the level of the aortic arch and other validated ultrasound criteria and cardiac MRI.
- Conditions
- Aortic Regurgitation
- Being tested
- transthoracic echocardiography, Cardiovascular Magnetic Resonance Imaging
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyDiagnostic test
This involves the acquisition of 1 additional sequence: a 10-minute sequence for transthoracic echocardiography.
Cardiovascular Magnetic Resonance ImagingDiagnostic test
This involves the acquisition of 1 additional sequence: a 10-minute sequence for Cardiovascular Magnetic Resonance Imaging 4D Flow.
| Study group | Role | What they receive |
|---|---|---|
| Transthoracic echocardiography and MRI | Experimental | The TransThoracic Echocardiography imaging data are collected exactly as for a standard examination. However, an additional measurement of the flow at the level of the left subclavian artery is performed, resulting in a 10-minute increase in the examination time. A Cardiovascular Magnetic Resonance Imaging 4D Flow is programmed within a maximum of 10 (no change in treatment that could skew the comparison). The usual procedure for MRI is not modified. The examination allows the acquisition of conventional 2D sequences of flow measurements, regurgitant volume and regurgitation fraction obtained at the level of the descending aorta and the sino-tubular junction of the ascending aorta. An additional 4D sequence is acquired increasing the examination time by 10 minutes. Receives: Diagnostic Test: transthoracic echocardiography; Diagnostic Test: Cardiovascular Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of absence of reflux in the left subclavian artery in transthoracic echocardiography and MRI 4D flow
It allows to evaluate the sensitivity/specificity of the presence of the left subclavian artery based holodiastolic regurgitation using transthoracic echocardiography on the one hand and 4D flow MRI on the other hand compared to the validated combined sonographic quantification criteria.
Measured: Day 1
Secondary outcomes (4)
Establish a tele-diastolic velocity threshold at the level of the left subclavian artery to quantify aortic regurgitation as severe by correlating the records with the other usual indices
It allows tele-diastolic velocity measurement at the left subclavian artery
Measured: Day 1
Establish a speed ratio threshold (systolic peak / tele-diastolic velocity) at the aortic arch and left subclavian artery
Diastolic / systolic speed ratio measurement at the left subclavian artery
Measured: Day 1
Evaluate the appearance of distal anterior interventricular flow and analyze its association with the severity of aortic leakage
It allows to evaluate the changes in coronary flow morphology (diastolic / systolic velocity, and S / D ratio) in anterior interventricular during severe aortic regurgitation
Measured: Day 1
Evaluate the 4D flow MRI parameters
It allows the measurement of regurgitant and anterograde volume in 4D flow MRI at the same sites as transthoracic echocardiography
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start4 May 2018
- Primary completion21 Sep 2020
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic RegurgitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier LOZINGUEZ, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549091
- Sponsor's protocol ID
- SUBCLAR
- Acronym
- SUBCLAR
- Status last verified
- Apr 2023
- First submitted
- 25 May 2018
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI as an Indicator of Severe Aortic Regurgitation
- ClinicalTrials.gov ID
- NCT03549091
- Acronym / sponsor ID
- SUBCLAR / SUBCLAR
- Conditions
- Aortic Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jun 2018 (actual)
- 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.
Aortic insufficiency (IA) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves. It represents about 10% of valvular pathologies but the annual mortality of nonoperated patients can be as high as 10% to 20%. The quantification of AI is therefore important as it can remain perfectly asymptomatic for a long time.
Doppler echocardiography is currently the key examination to confirm the presence of valvulopathy, to allow positive diagnosis of valve leakage regardless of location, to specify the etiology and mechanism of regurgitation. The quantification of IA requires, in transthoracic ultrasound, to take into account many parameters that individually have all certain limitations. The recommendations are therefore to have an integrative approach considering a combination of different parameters and an overall interpretation. This makes it possible to evaluate with greater precision the importance of the leak. Thus, there is the difficulty of quantifying moderate and severe AI for lack of a truly unique criterion. One of the evaluation criteria commonly used in transthoracic ultrasound is diastolic regurgitation in the aortic arch but this assessment is sometimes difficult. The left subclavian artery (SCG) is more accessible than the aortic arch in terms of the ultrasound window. The measurements will be easier to record since the vessel is more superficial and there are fewer air interpositions than for the aortic arch. The quantification of the AI based on this new element will be compared to the other previously validated ultrasound criteria. The investigators will use this study to describe the feasibility of collecting coronary flow in the artery (IVA), and they will compare systolic velocity, diastolic rate / systolic rate ratio compared to a control group without severe aortic insufficiency (grades 2 and 3). The flows recorded in the IVA will be compared to the importance of the aortic leakage according to its different modes of quantification (ultrasound and MRI). The aim of the study will be to show that diastolic reflux in the left subclavian artery is a marker of severe AI (grades 2 and 3) by comparing this regurgitation with that measured at the level of the aortic arch and other validated ultrasound criteria and cardiac MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transthoracic echocardiography and MRI | Experimental | Diagnostic Test: transthoracic echocardiography, Diagnostic Test: Cardiovascular Magnetic Resonance ImagingThe TransThoracic Echocardiography imaging data are collected exactly as for a standard examination. However, an additional measurement of the flow at the level of the left subclavian artery is performed, resulting in a 10-minute increase in the examination time. A Cardiovascular Magnetic Resonance Imaging 4D Flow is programmed within a maximum of 10 (no change in treatment that could skew the comparison). The usual procedure for MRI is not modified. The examination allows the acquisition of conventional 2D sequences of flow measurements, regurgitant volume and regurgitation fraction obtained at the level of the descending aorta and the sino-tubular junction of the ascending aorta. An additional 4D sequence is acquired increasing the examination time by 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient able to give informed consent to participate in the study
- Patient with transthoracic echocardiography and MRI prescription
Key exclusion criteria (5 listed)
- Contraindication to MRI
- Pathologies of the thoracic aorta (aneurism, dissection, stenosis)
- Pathologies of the left subclavian artery (stenosis, narrowing)
- Persistent arterial canal
- Arteriovenous fistula of the upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic echocardiographyThis involves the acquisition of 1 additional sequence: a 10-minute sequence for transthoracic echocardiography. | Diagnostic test | Transthoracic echocardiography and MRI |
| Cardiovascular Magnetic Resonance ImagingThis involves the acquisition of 1 additional sequence: a 10-minute sequence for Cardiovascular Magnetic Resonance Imaging 4D Flow. | Diagnostic test | Transthoracic echocardiography and MRI |
Primary outcome
Evaluation of absence of reflux in the left subclavian artery in transthoracic echocardiography and MRI 4D flow
Time frame: Day 1
It allows to evaluate the sensitivity/specificity of the presence of the left subclavian artery based holodiastolic regurgitation using transthoracic echocardiography on the one hand and 4D flow MRI on the other hand compared to the validated combined sonographic quantification criteria.
4 secondary outcomes
Establish a tele-diastolic velocity threshold at the level of the left subclavian artery to quantify aortic regurgitation as severe by correlating the records with the other usual indices
Time frame: Day 1
Establish a speed ratio threshold (systolic peak / tele-diastolic velocity) at the aortic arch and left subclavian artery
Time frame: Day 1
Evaluate the appearance of distal anterior interventricular flow and analyze its association with the severity of aortic leakage
Time frame: Day 1
Evaluate the 4D flow MRI parameters
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Olivier LOZINGUEZ, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transthoracic echocardiography and Cardiovascular Magnetic Resonance Imaging in people with Aortic Regurgitation, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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 France. 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?
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?
Evaluation of absence of reflux in the left subclavian artery in transthoracic echocardiography and MRI 4D flow (time frame: Day 1). 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 27 Apr 2023.