Aortic RuptureNCT03172390
In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance
A study testing 4D Cardiac Magnetic Resonance in people with Aortic Rupture, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Rupture
- What is being tested?
- 4D Cardiac Magnetic Resonance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2017to 4 Mar 2020
- 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
- Age ≥ 18 years.
- Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue.
- Informed consent for participation in the study
Who cannot join
- Contraindication to MRI
- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055
About this study
Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.
Read the detailed description
Although there is an increased lifetime risk when the aortic diameter exceeds 6 cm, predicting aneurysm progression is nearly impossible and dissection and rupture also occur at diameters under 6 cm. The assessment of aortic hemodynamics and the presence of altered flow patterns, as well as distribution and changes in wall shear stress (WSS) and the oscillatory shear index (OSI), using 4D phase contrast cardiovascular magnetic resonance (CMR) may provide further insights in how aneurysms develop and in assessing the risk of dissection. The purpose of this study was to investigate in patients with dilated ascending aorta the flow patterns and vessel wall parameters in order to correlate these hemodynamics factors with changes in aorta size.
- Conditions
- Aortic Rupture
- Being tested
- 4D Cardiac Magnetic Resonance
- Keywords
- Ascending aorta aneurysm, Aortic wall shear stress, 4D phase contrast Cardiovascular Magnetic Resonance, Aortic dissection
- Medical subject headings
- Aortic Rupture, Aneurysm, Ascending Aorta, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D Cardiac Magnetic ResonanceDevice
4D Cardiac Magnetic Resonance for patients with a ascending aorta dilatation without current indication for surgery for measured parameters of ascending aorta
| Study group | Role | What they receive |
|---|---|---|
| Cohort of patients : ascending aorta dilatation | Experimental | measure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance Receives: Device: 4D Cardiac Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta
Aorta diameter [mm] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR) Wall shear stress (WSS) in aorta [Pa] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR).
Measured: From baseline to 1 year
Secondary outcomes (1)
Aorta parameters associated with change in aorta diameter
Aorta parameters are a composite outcome :
- the oscillatory shear index (OSI)
- pulse wave velocity=PWV [m/s] assessed by 4D phase contrast cardiovascular magnetic resonance (CMR). Aorta diameter [mm] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR)
Measured: From baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start11 Oct 2017
- Primary completion11 Apr 2019
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic RuptureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172390
- Sponsor's protocol ID
- 1708028
- Other IDs
- 2017-A00871-52
- Status last verified
- Nov 2020
- First submitted
- 23 May 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT03172390
- Acronym / sponsor ID
- 1708028
- Conditions
- Aortic Rupture
- Keywords
- Ascending aorta aneurysm, Aortic wall shear stress, 4D phase contrast Cardiovascular Magnetic Resonance, Aortic dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 1 Jun 2017 (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.
Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.
Detailed description
Although there is an increased lifetime risk when the aortic diameter exceeds 6 cm, predicting aneurysm progression is nearly impossible and dissection and rupture also occur at diameters under 6 cm. The assessment of aortic hemodynamics and the presence of altered flow patterns, as well as distribution and changes in wall shear stress (WSS) and the oscillatory shear index (OSI), using 4D phase contrast cardiovascular magnetic resonance (CMR) may provide further insights in how aneurysms develop and in assessing the risk of dissection. The purpose of this study was to investigate in patients with dilated ascending aorta the flow patterns and vessel wall parameters in order to correlate these hemodynamics factors with changes in aorta size.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients : ascending aorta dilatation | Experimental | Device: 4D Cardiac Magnetic Resonancemeasure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue.
- Informed consent for participation in the study
Key exclusion criteria (2 listed)
- Contraindication to MRI
- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.
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 |
|---|---|---|
| 4D Cardiac Magnetic Resonance4D Cardiac Magnetic Resonance for patients with a ascending aorta dilatation without current indication for surgery for measured parameters of ascending aorta | Device | Cohort of patients : ascending aorta dilatation |
Primary outcome
Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta
Time frame: From baseline to 1 year
Aorta diameter [mm] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR) Wall shear stress (WSS) in aorta [Pa] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR).
1 secondary outcome
Aorta parameters associated with change in aorta diameter
Time frame: From baseline to 1 year
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 13 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D Cardiac Magnetic Resonance in people with Aortic Rupture, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 2 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 13 Nov 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 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?
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?
Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta (time frame: From baseline to 1 year). 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 13 Nov 2020.