Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03423316
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2018-01-23
Brief Title:
Functional MRI of the Lower Extremities
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Stress-rest Calf Muscle Perfusion a Functional Diagnostic Test for Peripheral Arterial Disease PAD
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
In this project the investigators propose to use high-resolution magnetic resonance imaging MRI to measure blood perfusion in different groups of calf muscle This imaging approach is standard of care for evaluation of coronary artery disease CAD and has never been successfully applied to PAD Preliminary results show distinct patterns of muscle perfusion between healthy and PAD patients and thus great promise of the technique The investigators will first verify the reproducibility of the technique and then compare the calf muscle perfusion measures in PAD patients against healthy age-matched controls This comparison will test the feasibility of detecting functional abnormality in PAD patients After the baseline scans the PAD patients will opt to undergo a 12-week supervised exercise therapy and then a post-therapy MRI scan Comparison of the pre- and post-therapy measurements will indicate how the therapy improves the calf-muscle perfusion and how this perfusion change correlates with increases in patients walking ability
The long term goals of this project are to develop an improved diagnostic test for patients with PAD to predict who will benefit from therapeutic intervention The MRI perfusion studies of calf muscle can be performed in conjunction with routine peripheral MR angiography to assess the functional significance of vascular stenosis
The long term goals of this project are to develop an improved diagnostic test for patients with PAD to predict who will benefit from therapeutic intervention The MRI perfusion studies of calf muscle can be performed in conjunction with routine peripheral MR angiography to assess the functional significance of vascular stenosis
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None