Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
Primary Purpose
Aortic Valve Disease, Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Valve Disease focused on measuring 4D flow
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)
Sites / Locations
- Universitair Ziekenhuis Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
4Dflow MRI parallel imaging
4D flow ktARC parallel imaging
Arm Description
4D flow MRI with conventional parallel imaging
4D flow MRI kt ARC spatiotemporal parallel imaging
Outcomes
Primary Outcome Measures
the bloodflow pattern
Secondary Outcome Measures
wall sheer stress
Full Information
NCT ID
NCT02467062
First Posted
June 2, 2015
Last Updated
December 5, 2016
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02467062
Brief Title
Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
Official Title
Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Aneurysm
Keywords
4D flow
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4Dflow MRI parallel imaging
Arm Type
Active Comparator
Arm Description
4D flow MRI with conventional parallel imaging
Arm Title
4D flow ktARC parallel imaging
Arm Type
Other
Arm Description
4D flow MRI kt ARC spatiotemporal parallel imaging
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI measurement to evualuate for 4D blood flow pattern
Primary Outcome Measure Information:
Title
the bloodflow pattern
Time Frame
1 day
Secondary Outcome Measure Information:
Title
wall sheer stress
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaoru Tanaka, MD PhD
Organizational Affiliation
Department of Radiology, Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Nijs, MD
Organizational Affiliation
Brussels Center for Aortic and Cardiovascular Connective Tissue Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams Brabant
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
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