Clinical Trials Directory

Trials / Completed

CompletedNCT02467062

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Universitair Ziekenhuis Brussel · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEMRIMRI measurement to evualuate for 4D blood flow pattern

Timeline

Start date
2015-09-01
Primary completion
2016-09-01
Completion
2016-09-01
First posted
2015-06-09
Last updated
2016-12-06

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02467062. Inclusion in this directory is not an endorsement.