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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 11, 2019

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.

Interventions

  • Device: 4D Cardiac Magnetic Resonance
    • 4D Cardiac Magnetic Resonance for patients with a ascending aorta dilatation without current indication for surgery for measured parameters of ascending aorta

Arms, Groups and Cohorts

  • Experimental: Cohort of patients : ascending aorta dilatation
    • measure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • Aorta parameters associated with change in aorta diameter
    • Time Frame: From baseline to 1 year
    • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor

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