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

NCT ID: NCT02467062

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Aortic Valve Disease; Aortic Aneurysm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

4Dflow MRI parallel imaging

4D flow MRI with conventional parallel imaging

Group Type: ACTIVE_COMPARATOR

MRI

Intervention Type: DEVICE

MRI measurement to evualuate for 4D blood flow pattern

4D flow ktARC parallel imaging

4D flow MRI kt ARC spatiotemporal parallel imaging

Group Type: OTHER

MRI

Intervention Type: DEVICE

MRI measurement to evualuate for 4D blood flow pattern

Interventions

MRI

MRI measurement to evualuate for 4D blood flow pattern

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Veerle Van Mossevelde

Data Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaoru Tanaka, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Universitair Ziekenhuis Brussel

Jan Nijs, MD

Role: PRINCIPAL_INVESTIGATOR

Brussels Center for Aortic and Cardiovascular Connective Tissue Disease

Locations

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, Belgium

Countries

Belgium

Other Identifiers

4D AORTIC FLOW MRI

Identifier Type: -

Identifier Source: org_study_id