Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405971
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-28
Brief Title:
Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms METTLE
Sponsor:
Ming Lv
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms a Prospective Randomized Study METTLE
Status:
RECRUITING
Status Verified Date:
2024-08
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:
METTLE
Brief Summary:
Vertebrobasilar dissecting aneurysms VBDAs are one of the most important causes of stroke in young and middle-aged people and the natural history of VBDAs is complex and varied often leading to high rates of disability and mortality For some patients with VBDAs who are not suitable for surgical entrapment and intervention pharmacologic therapy may be used to slow the progression of VBDAs Metformin MET has been shown to act as an anti-inflammatory anti-oxidative stress and improve vascular endothelial function by inhibiting smooth muscle cell phenotypic transformation proliferation migration and apoptosis thereby reducing the incidence of intracranial aneurysms and rupture rates and MET may be a suitable candidate Inflammatory response plays an important role in the occurrence development and rupture of VBDAs Inflammatory response in the aneurysm wall can cause endothelial and smooth muscle cell injury and apoptosis leading to degenerative changes in the vessel wall and increasing the risk of rupture of VBDAs High-resolution magnetic resonance vessel wall imaging HR-VWI which can clearly show the structure of the vessel wall and reflect the active degree of inflammatory reaction in the aneurysm wall has been widely used in the assessment of intracranial aneurysm instability In this study we propose to conduct a multicenter prospective randomized study to investigate whether MET reduces the degree of aneurysm wall inflammatory response in VBDAs by performing HR-VWI scans in patients with VBDAs and obtaining quantitative parameters reflecting the inflammatory response of the aneurysm wall
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