Aortic Valve Disease Clinical Trial
Official title:
Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic valve diseases.
Currently, the timing of the replacement of the ascending aorta is solely based on the
aortic diameter and concomitant valvular dysfunction and the most recent ESC guideline
proposes surgical intervention of ascending aortic aneurysm in patients who have a maximal
aortic diameter ≥ 55mm, regardless of etiology. On the contrary, a recent publication by
Rylski et al showed that most of the dissections occur at diameters smaller than 55 mm.
Several publictions have shown that the flow profile and wall sheer stress derived from 4D
flow MRI are significantly different between the valve morphology, the type of the aneurysm
(tubular or diffuse enlargement) and pre and postoperative patients. Clinical implementation
of 4D flow may enable us to stratify the patients with aortic and/or aortic valve diseases,
especially in regard to the risk of ruptures. The patients with aortic/aortic valve disease
will be referred to 4D flow MRI and contrast-enhanced angiografie from the aorta clinic.
Phase 1: 6 healty adult volunteers will be scanned prior to the scan of the patients and
settings would be optimised for 4D flow MRI and the contrast will not be given.
Phase 2: 30 patients either scheduled for surgical treatment of their aortic disease,
post-operative patients and patients under surveillance for known aortic root and/or aortic
valve disease will be imaged. Only patients having a clinical indication for an MRI of the
aorta/aortic valve will be included.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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