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In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance

Primary Purpose

Aortic Rupture

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
4D Cardiac Magnetic Resonance
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Rupture focused on measuring Ascending aorta aneurysm, Aortic wall shear stress, 4D phase contrast Cardiovascular Magnetic Resonance, Aortic dissection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindication to MRI
  • Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort of patients : ascending aorta dilatation

Arm Description

measure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Full Information

First Posted
May 23, 2017
Last Updated
November 12, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03172390
Brief Title
In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance
Official Title
In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Rupture
Keywords
Ascending aorta aneurysm, Aortic wall shear stress, 4D phase contrast Cardiovascular Magnetic Resonance, Aortic dissection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort of patients : ascending aorta dilatation
Arm Type
Experimental
Arm Description
measure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance
Intervention Type
Device
Intervention Name(s)
4D Cardiac Magnetic Resonance
Intervention Description
4D Cardiac Magnetic Resonance for patients with a ascending aorta dilatation without current indication for surgery for measured parameters of ascending aorta
Primary Outcome Measure Information:
Title
Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta
Description
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).
Time Frame
From baseline to 1 year
Secondary Outcome Measure Information:
Title
Aorta parameters associated with change in aorta diameter
Description
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)
Time Frame
From baseline to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Contraindication to MRI Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
State/Province
Loire
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance

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