Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02387255
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2015-02-19
Brief Title:
Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAA-MRE
Brief Summary:
The main objective of this study is to utilize Magnetic Resonance Elastography MRE to determine tissue stiffness of abdominal aortic aneurysms AAA For patients with AAA MRE is a more sensitive and superior method of determining the risk for rupture of AAA based on stiffness estimates when compared to the current crude method of assessing risk based on measurement of the diameter of the aneurysm The investigators will also validate the stiffness estimates against gold standard ie mechanical testing and histopathology only AAA patients undergoing AAA surgery
Detailed Description:
Currently MRE is a clinical tool used to assess hepatic fibrosis at many institutions MRE is superior to invasive techniques ie biopsies and mechanical testing in that it is noninvasive and can be performed in vivo under physiologic conditions MRE could make diagnosing stiffness widely available and could revolutionize the diagnosis and treatment of numerous other diseases affecting stiffness of soft tissues
Aortic wall stiffness is a fundamental biomechanical parameter that reflects the structural integrity of normal and aneurysmal aortic tissue AAAs enlarge over time leading to sudden rupture and death in up to 90 of patients Surgical or endovascular aneurysm repair EVAR is recommended for AAAs 55 cm in diameter However previous studies have reported a high percentage 13 of smaller AAAs 5 cm go on to rupture and an even higher percentage 60 of larger AAAs 5 cm remain stable Despite the poor prognostic value of aortic diameter it is still the primary parameter used to time surgical repair It is known that changes in stiffness of AAA can reveal important information on extra-cellular matrix content a key factor in the pathophysiological development of AAA and the risk for rupture A non-invasive spatially resolved estimate of aortic stiffness may provide a superior determinant of the risk for rupture compared to the currently used anatomical measures The relationship between non-invasively measured wall stiffness WS and the structural integrity of the aortic wall must be further elucidated Therefore aortic MRE can be used as a noninvasive tool to estimate the stiffness of AAAs and can provide superior diagnostic and prognostic information in patients with developing AAA disease
Entry to this study is open to men and women aged 18 years and older and to all racial and ethnic subgroups Two separate groups of patients with AAA will be recruited One group will be patients who have been diagnosed with AAA and are monitored to observe the size of the AAA The other group is comprised of patients who are scheduled for surgical repair of AAA
Aortic wall stiffness is a fundamental biomechanical parameter that reflects the structural integrity of normal and aneurysmal aortic tissue AAAs enlarge over time leading to sudden rupture and death in up to 90 of patients Surgical or endovascular aneurysm repair EVAR is recommended for AAAs 55 cm in diameter However previous studies have reported a high percentage 13 of smaller AAAs 5 cm go on to rupture and an even higher percentage 60 of larger AAAs 5 cm remain stable Despite the poor prognostic value of aortic diameter it is still the primary parameter used to time surgical repair It is known that changes in stiffness of AAA can reveal important information on extra-cellular matrix content a key factor in the pathophysiological development of AAA and the risk for rupture A non-invasive spatially resolved estimate of aortic stiffness may provide a superior determinant of the risk for rupture compared to the currently used anatomical measures The relationship between non-invasively measured wall stiffness WS and the structural integrity of the aortic wall must be further elucidated Therefore aortic MRE can be used as a noninvasive tool to estimate the stiffness of AAAs and can provide superior diagnostic and prognostic information in patients with developing AAA disease
Entry to this study is open to men and women aged 18 years and older and to all racial and ethnic subgroups Two separate groups of patients with AAA will be recruited One group will be patients who have been diagnosed with AAA and are monitored to observe the size of the AAA The other group is comprised of patients who are scheduled for surgical repair of AAA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None