Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03138434
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2017-05-01
Brief Title:
Advanced MRI in AAA
Sponsor:
Ron Balm
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Advanced MRI in AAA
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient acquisitions for DCE-MRI and 4D flow but not for T1T2-mapping due to lack of ILT in some participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine whether advanced MRI sequences can provide robust and clinically relevant information about abdominal aortic aneurysms AAAs The MRI sequences will study outcomes related to blood flow inside AAA microvasculature of the AAA vessel wall and intraluminal thrombus inside AAA
Robustness of these MRI sequences will be determined with testing of feasibility and reproducibility Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity Disease severity will be expressed by AAA diameter
It is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression
Robustness of these MRI sequences will be determined with testing of feasibility and reproducibility Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity Disease severity will be expressed by AAA diameter
It is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression
Detailed Description:
This prospective study evaluates the feasibility reproducibility and clinical relevance of MRI sequences in adults with an abdominal aortic aneurysm AAA
The MRI sequences and their primary outcomes are
Four-dimensional 4D flow MRI and wall shear stress WSS
Dynamic Contrast-Enhanced DCE MRI and kinetic transport constant Ktrans
T1 and T2 mapping T1 and T2 relaxation times
Feasibility is tested by the production of high-quality images that enable calculation of the primary outcomes Reproducibility is tested by calculating interscan intra- and interobserver variability Clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by AAA diameter
The MRI sequences and their primary outcomes are
Four-dimensional 4D flow MRI and wall shear stress WSS
Dynamic Contrast-Enhanced DCE MRI and kinetic transport constant Ktrans
T1 and T2 mapping T1 and T2 relaxation times
Feasibility is tested by the production of high-quality images that enable calculation of the primary outcomes Reproducibility is tested by calculating interscan intra- and interobserver variability Clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by AAA diameter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None