Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT03138434
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced MRI in AAA
Sponsor:
Ron Balm
Organization:
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 T1/T2-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:
False
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?: