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

Not Applicable

Completed

• Conditions: Aortic Rupture
• Interventions: Device: 4D Cardiac Magnetic Resonance

• Registration Number: NCT03172390
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Study Start: 2017-10-11
• Primary Completion: 2019-04-11
• Study Completion: 2020-03-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort of patients : ascending aorta dilatation	4D Cardiac Magnetic Resonance	measure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance

Primary Outcome Measures

Name	Time	Method
Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta	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 Outcome Measures

Name	Time	Method
Aorta parameters associated with change in aorta diameter	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)

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, Loire, France