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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03172390

Enrollment

Registered

2017-06-01

Start date

2017-10-11

Completion date

2020-03-04

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Rupture

Keywords

Ascending aorta aneurysm, Aortic wall shear stress, 4D phase contrast Cardiovascular Magnetic Resonance, Aortic dissection

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.

Interventions

DEVICE4D 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Prospective cohort

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026