Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemodynamic Changes in the Aorta After Endovascular Treatment of the Aortic Dissection (4DAo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669055
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Aortic dissection (AD) is a serious pathology affecting one person for 300 000 habitants per year. In case of complicated AD on the descending aorta, it is necessary to perform an endovascular surgery in association with medical treatment. An endoprosthesis is implanted on the descending thoracic aorta in order to close the main intimal tear. This closure lead to an increase in the thoracic true lumen diameter, a decrease in the thoracic false lumen diameter, a better perfusion of the aortic branches. Furthermore, even in case of open surgical treatment of the ascending aorta it can be necessary to perform an endovascular treatment on the descending aorta, either to prevent and treat aneurysmal evolution or to treat patent malperfusion syndrome.

CT and Magnetic Resonance angiography, by the realization of an aortic morphologic evaluation, are the two key imaging exams in the DA. Nevertheless, CT can't provide aortic dynamic evaluation, contrary to MRI. This exam, thanks to the phase-contrast sequence can measure velocity and flow data in vessels, including aorta but also true and false lumen in the AD. Thus, by verifying the perfusion of the aortic true lumen and the aortic branches it is possible to perform an early evaluation of the endovascular treatment of the DA.

Actually, only one study has realized an aortic dynamic evaluation on the AD, unfortunately this study was limited to non-operated patients.

In order to assess the place of MRI in the AD, the ingestigation propose to determine if phase-contrast MRI is able to evaluate the impact of the endovascular treatment on the hemodynamic state of the aorta and its branches.


Condition or disease Intervention/treatment Phase
Aortic Dissection Other: Magnetic Resonance Imaging Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Radiological Study of the Hemodynamic Changes in the Aorta and Its Branches Before and After Endovascular Treatment of the Aortic Dissection
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : March 7, 2020
Estimated Study Completion Date : March 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Pre-operative and post operative Magnetic Resonance Imaging
Realization of an angio-MRI with 4D phase contrast sequence before and after the endovascular treatment of the aortic dissection
Other: Magnetic Resonance Imaging
Realization of a MRI before and after the endovascular treatment of the aortic dissection. Use of the 4D phase-contrast sequence during the MRI.




Primary Outcome Measures :
  1. Comparative measurement of the flow in the aortic true lumen before and after endovascular treatment of the aortic dissection [ Time Frame: change from day 0 and day 16 ]
    The flows are measured in ml/s at several locations of the aortic true lumen. The flows are measured during the two MRI and compared with each other.


Secondary Outcome Measures :
  1. Comparative measurement of the flow in the aortic false lumen before and after endovascular treatment of the aortic dissection [ Time Frame: change from day 0 and day 16 ]
    The flows are measured in ml/s at several locations of the aortic false lumen. The flows are measured during the two MRI and compared with each other.

  2. Comparative measurement of the flow in the aortic branches before and after endovascular treatment of the aortic dissection [ Time Frame: day 0 and day 16 ]

    The flows are measured in ml/s in the celiac artery, the superior mesenteric artery, the inferior mesenteric artery, the right and left renal artery, the right and left primitive iliac artery.

    The flows are measured during the two MRI and compared with each other.


  3. Comparative measurement of the number of intimal tear identified through 4D phase-contrast MRI relative to the number of intimal tear identified through Angio MRI before endovascular treatment of the aortic dissection [ Time Frame: change from day 0 and day 16 ]

    In the 4D phase-contrast MRI, an intimal tear is identified by a streamline going from the true lumen to the false lumen.

    In the Angio MRI, an intimal tear is identified by the visualization of the passage of the contrast agent from the true lumen to the false lumen.


  4. Flow measurement through intimal tear with 4 Dimensions (4D) phase-contrast MRI before and after endovascular treatment of the aortic dissection [ Time Frame: change from day 0 and day 16 ]
    The intimal tears are identified thanks to the Angio MRI. The flows are measured during the two MRI and compared with each other.

  5. Comparative measurement through 4D phase-contrast MRI of the shear forces before and after endovascular treatment of the aortic dissection [ Time Frame: change from day 0 and day 16 ]
    Shear forces are measured thanks to the 4D phase contrast MRI.

  6. Comparative measurement through 4D phase-contrast MRI of parietal energy before and after endovascular treatment of the aortic dissection [ Time Frame: change from day 0 and day 16 ]
    Parietal energy is measured thanks to the 4D phase contrast MRI.

  7. Comparative measurement through 4D phase-contrast MRI of the presence of helicoidal flow before and after endovascular treatment of the aortic dissection [ Time Frame: change from day 0 and day 16 ]

    The presence of a perpendicular flow to the main aortic flow is identified thanks to the 4D phase contrast MRI.

    The helicoidal flow is quantified by the degree of rotation between the beginning of the end of the cardiac cycle in millisecond.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with an aortic dissection requiring endovascular treatment
  • The endovascular treatment will be indicated according to the guidelines after medical, radiological and surgical multidisciplinary discussion in our hospital.
  • Patients that have signed the informed consent form.
  • Members of a social protection scheme.

Exclusion Criteria:

  • Patients with an aortic dissection requiring an emergency intervention
  • Patients with a contra-indication to endovascular treatment
  • Contra-indication to MRI: claustrophobia, ferromagnetic materials: pacemaker, prosthetic heart valve, implantable cardioverter defibrillators, vascular clip
  • Pregnancy
  • Breastfeeding
  • Dementia
  • Patients under guardianship
  • Patients with difficulty in understanding the French language

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): NCT03669055


Contacts
Layout table for location contacts
Contact: Benoit Cosset, MD 472115170 ext +33 benoit.cosset@chu-lyon.fr
Contact: Adeline MANSUY, CRA 472115170 ext +33 GHE.ARC-Imagerie@chu-lyon.fr

Locations
Layout table for location information
France
Hopital Louis Pradel Recruiting
Bron, France
Contact: Benoit Cosset, MD    472115170 ext +33    benoit.cosset@chu-lyon.fr   
Contact: Adeline Mansuy, CRA    472115170 ext +33    GHE.ARC-Imagerie@chu-lyon.fr   
Principal Investigator: Benoit Cosset, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03669055    
Other Study ID Numbers: 69HCL18_0361
2018-A01742-53 ( Other Identifier: n°ID-RCB )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
aortic dissection
hemodynamic
4D flow phase contrast MRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases