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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467062
• Other study ID #: 4D AORTIC FLOW MRI
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: December 5, 2016
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Diseases
• Aortic Valve Disease

Intervention

Device:
• MRI
MRI measurement to evualuate for 4D blood flow pattern

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the bloodflow pattern		1 day	Yes
Secondary	wall sheer stress		1 day	Yes