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CT Evaluation of Intimal Flap Mobility (CT-MOBILITY)

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ClinicalTrials.gov Identifier: NCT03787277
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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.

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.


Condition or disease
Aortic Dissection Type A

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: CT Evaluation of Intimal Flap Mobility as a Potential Predictor of Residual Type B Dissection Evolution
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient having ascending aorta replacement for aortic dissection
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • Patient expressing opposition to participating in the study
  • Patient under the protection of justice
  • Patient under guardianship or curatorship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787277


Contacts
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Contact: Mickaël OHANA, MD 33 3 69 55 11 17 mickael.ohana@chru-strasbourg.fr
Contact: Joseph ATLAN, MD 33 3 69 55 10 83 joseph.atlan@chru-strasbourg.fr

Locations
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France
Service de Radiologie B - NHC Recruiting
Strasbourg, France
Contact: Mickaël OHANA, MD    33 3 69 55 11 17    mickael.ohana@chru-strasbourg.fr   
Contact: Joseph ATLAN, MD    33 3 69 5510 83    joseph.atlan@chru-strasbourg.fr   
Principal Investigator: Mickaël OHANA, MD         
Sub-Investigator: Joseph ATLAN, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03787277     History of Changes
Other Study ID Numbers: 7310
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Strasbourg, France:
Aortic Dissection Type A
Post operative residual aortic dissection
Aneurysmal progression of the dissected aorta
Intimal flap mobility

Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases