Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-06
Brief Title:
Beta-blockade in Unruptured Intracranial Aneurysm
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
Official Title:
Beta-blockade in Unruptured Intracranial Aneurysm
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
BBLURAN
Brief Summary:
Subarachnoid haemorrhage is a devastating type of stroke with high mortality and morbidity rate In approximately 85 of cases it is caused by an intracranial aneurysm rupture Majority of patients with diagnosed intracranial aneurysm are eligible for interventional treatment however some patients are managed conservatively Currently the only recommendations for patients with conservatively managed intracranial aneurysms are routine imaging follow-ups and minimization of rupture risk factors There are no medications proven to decrease risk of aneurysm rupture that might be prescribed to such patients In preliminary study the investigators found that patients with intracranial aneurysms who took β-blockers had significantly smaller aneurysm rupture rate and dome size as well as more favorable hemodynamic parameters No other antihypertensive drugs showed similar associations Therefore in this project the investigators aim to further analyze the impact of β-blocker intake on fate of intracranial aneurysm and find possible explanations for its protective role The investigators aim to perform a randomised double-blind placebo-controlled clinical trial One hundred patients with unruptured intracranial aneurysm qualified to conservative management will be enrolled Two arms 50 patients each will be receiving nebivolol or matching placebo Treatment in each arm will last 12 months The following examinations will be performed at baseline and at 6 and 12 months clinical assessment angio-MRI with vessel wall imaging Doppler ultrasound to extract blood flow waveforms from Internal Carotid Artery Vertebral Artery Middle Cerebral Artery Anterior Cerebral Artery and Posterior Cerebral Artery as well as blood samples Based on the results the investigators will assess changes in aneurysm size and wall contrast enhancement The investigators will also analyze levels of possible aneurysm growth biomarkers in peripheral blood Additionally the investigators will prepare three-dimensional models of the artery harbouring aneurysm and perform patient-specific computer modelling of blood flow through such artery to assess hemodynamic parameters of aneurysm dome All obtained measurements will be compared at baseline and at 6 and 12 months The investigators hypothesize that in comparison to the placebo group β-blocker therapy in patients with unruptured intracranial aneurysm will contribute to favorable changes in hemodynamic parameters of aneurysm dome decrease wall degradation process and prevent from aneurysm growth
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?:
False
Is an FDA AA801 Violation?:
None