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OpenTrials
Completed

NCT Number: NCT03172390

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

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.

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Key information

Conditions

Aortic Rupture Acute Aortic Syndrome Aneurysm Aneurysm, Ascending Aorta Aneurysm, Ruptured Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Rupture Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4D Cardiac Magnetic Resonance

Device

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

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 1, 2017
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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