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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02467062
Enrollment
36
Registered
2015-06-09
Start date
2015-09-30
Completion date
2016-09-30
Last updated
2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Aortic Valve Disease

Keywords

4D flow

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.

Interventions

DEVICEMRI

MRI measurement to evualuate for 4D blood flow pattern

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
the bloodflow pattern1 day

Secondary

MeasureTime frame
wall sheer stress1 day

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026