Aortic Dissection Type ACT-MOBILITYNCT03787277
CT Evaluation of Intimal Flap Mobility
An observational study of Aortic Dissection Type A, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Type A aortic dissection is an emergency condition, defined by the appearance of an intimal flap within the ascending aorta. Urgent treatment is required, with surgical replacement of - at minima - the tubular portion of the ascending aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection Type A
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2019to 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient having ascending aorta replacement for aortic dissection
Who may be able to join
- Major patient (≥18 years old)
- Ascending aorta replacement for aortic dissection, between 2010 and 2015 (timeframe established to allow for a significant follow-up period after surgery)
- Residual type B dissection after surgery availability of thin-slices good quality CT angiography before (at least one) and after (at least two) the surgery.
Who cannot join
- Patient expressing opposition to participating in the study
- Patient under the protection of justice
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Radiologie B - NHC
Strasbourg
Mickaël OHANA, MD, 33 3 69 55 11 17, mickael.ohana@chru-strasbourg.fr
Joseph ATLAN, MD, 33 3 69 5510 83, joseph.atlan@chru-strasbourg.fr
About this study
Official title: CT Evaluation of Intimal Flap Mobility as a Potential Predictor of Residual Type B Dissection Evolution
Type A aortic dissection is an emergency condition, defined by the appearance of an intimal flap within the ascending aorta. Urgent treatment is required, with surgical replacement of - at minima - the tubular portion of the ascending aorta.
After surgery, a majority of patients will still have a residual aortic dissection involving the aortic arch and/or the descending aorta. Long-term survival in these patients can be hindered by the apparition of an aneurysmal progression of the dissected aorta, with risk of rupture, thrombose and/or embolism. Consequently, this condition requires frequent follow-up imaging examinations, usually by Computed Tomography Angiography (CTA), to monitor the extension of the dissection and the diameters of the dissected aorta. Patient management is therefore based on passive follow-up of the disease, as no definitive clinical or imaging features can predict the potential evolution (or the absence of) towards an aneurysmal evolution.
Read more
Therefore, one can understand the important need for accurate predictors of aneurysmal dilatation of post-operative residual dissection.
CTA has the ability to visualize the intimal flap motion, by averaging at least 3 or 4 cardiac cycles over a non-gated arterial acquisition.
This intimal flap mobility varies greatly between patients, between the localization and the extension of the dissection, and between acute and chronic dissections. It is thought that chronic dissections with immobile flap might be less prone to aneurysmal evolution.
The investigators hypothesize that this mobility could be a prognostic marker for the evolution towards aortic dilatation: flap that would remain highly mobile after initial surgery could be an additional marker towards an aneurysmal evolution, while immobile flap could be on the contrary a marker of stability.
Intimal flap motion can already be qualitatively and quantitatively assessed in CTA when ECG-synchronization is used. However, this technique has a limited availability and significantly increases the total radiation dose, therefore limiting its use in routine practice. Being able to quantify this marker using routine non ECG-gated CTA could be a significant addition to the literature, as it is currently unknown if this is feasible/relevant.
- Conditions
- Aortic Dissection Type A
- Keywords
- Aortic Dissection Type A, Post operative residual aortic dissection, Aneurysmal progression of the dissected aorta, Intimal flap mobility
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the mobility of the intimal flap with CT angiography without the use of ECG synchronization
The study concerns patients operated at Strasbourg University Hospitals for the replacement of the ascending aorta for aortic dissection from 2010 to 2015
Measured: The period from January 1st, 2010 to December 31, 2015 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start8 Jan 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type AStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787277
- Sponsor's protocol ID
- 7310
- Acronym
- CT-MOBILITY
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Evaluation of Intimal Flap Mobility as a Potential Predictor of Residual Type B Dissection Evolution
- ClinicalTrials.gov ID
- NCT03787277
- Acronym / sponsor ID
- CT-MOBILITY / 7310
- Conditions
- Aortic Dissection Type A
- Keywords
- Aortic Dissection Type A, Post operative residual aortic dissection, Aneurysmal progression of the dissected aorta, Intimal flap mobility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Dec 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.
Type A aortic dissection is an emergency condition, defined by the appearance of an intimal flap within the ascending aorta. Urgent treatment is required, with surgical replacement of - at minima - the tubular portion of the ascending aorta.
After surgery, a majority of patients will still have a residual aortic dissection involving the aortic arch and/or the descending aorta. Long-term survival in these patients can be hindered by the apparition of an aneurysmal progression of the dissected aorta, with risk of rupture, thrombose and/or embolism. Consequently, this condition requires frequent follow-up imaging examinations, usually by Computed Tomography Angiography (CTA), to monitor the extension of the dissection and the diameters of the dissected aorta. Patient management is therefore based on passive follow-up of the disease, as no definitive clinical or imaging features can predict the potential evolution (or the absence of) towards an aneurysmal evolution.
Therefore, one can understand the important need for accurate predictors of aneurysmal dilatation of post-operative residual dissection.
CTA has the ability to visualize the intimal flap motion, by averaging at least 3 or 4 cardiac cycles over a non-gated arterial acquisition.
This intimal flap mobility varies greatly between patients, between the localization and the extension of the dissection, and between acute and chronic dissections. It is thought that chronic dissections with immobile flap might be less prone to aneurysmal evolution.
The investigators hypothesize that this mobility could be a prognostic marker for the evolution towards aortic dilatation: flap that would remain highly mobile after initial surgery could be an additional marker towards an aneurysmal evolution, while immobile flap could be on the contrary a marker of stability.
Intimal flap motion can already be qualitatively and quantitatively assessed in CTA when ECG-synchronization is used. However, this technique has a limited availability and significantly increases the total radiation dose, therefore limiting its use in routine practice. Being able to quantify this marker using routine non ECG-gated CTA could be a significant addition to the literature, as it is currently unknown if this is feasible/relevant.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient having ascending aorta replacement for aortic dissection
Key inclusion criteria (3 listed)
- Major patient (≥18 years old)
- Ascending aorta replacement for aortic dissection, between 2010 and 2015 (timeframe established to allow for a significant follow-up period after surgery)
- Residual type B dissection after surgery availability of thin-slices good quality CT angiography before (at least one) and after (at least two) the surgery.
Key exclusion criteria (3 listed)
- Patient expressing opposition to participating in the study
- Patient under the protection of justice
- Patient under guardianship or curatorship
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
Evaluate the mobility of the intimal flap with CT angiography without the use of ECG synchronization
Time frame: The period from January 1st, 2010 to December 31, 2015 will be examined
The study concerns patients operated at Strasbourg University Hospitals for the replacement of the ascending aorta for aortic dissection from 2010 to 2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
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 Aortic Dissection Type A, run by University Hospital, Strasbourg, France 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 3 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 15 Feb 2019. 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?
Contact Mickaël OHANA, MD (33 3 69 55 11 17, mickael.ohana@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the mobility of the intimal flap with CT angiography without the use of ECG synchronization (time frame: The period from January 1st, 2010 to December 31, 2015 will be examined). 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 15 Feb 2019.