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

Not Applicable

Completed

• Conditions: Aortic Valve Disease; Aortic Aneurysm
• Interventions: Device: MRI

• Registration Number: NCT02467062
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Study Start: 2015-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4D flow ktARC parallel imaging	MRI	4D flow MRI kt ARC spatiotemporal parallel imaging
4Dflow MRI parallel imaging	MRI	4D flow MRI with conventional parallel imaging

Primary Outcome Measures

Name	Time	Method
the bloodflow pattern	1 day

Secondary Outcome Measures

Name	Time	Method
wall sheer stress	1 day

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Vlaams Brabant, Belgium