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Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.

U

Universitair Ziekenhuis Brussel

Status

Completed

Conditions

Aortic Valve Disease
Aortic Aneurysm

Treatments

Device: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT02467062
4D AORTIC FLOW MRI

Details and patient eligibility

About

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.

Full description

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with aortic aneurysm and/or aortic valve disease older than 18 years.

Exclusion criteria

  • Patients <18 years
  • Pregnancy.
  • Patients who have known contraindiction of MRI (ex claustrophobia, ICD, insulin pump etc)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

4Dflow MRI parallel imaging
Active Comparator group
Description:
4D flow MRI with conventional parallel imaging
Treatment:
Device: MRI
4D flow ktARC parallel imaging
Other group
Description:
4D flow MRI kt ARC spatiotemporal parallel imaging
Treatment:
Device: MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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