The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Active, not recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Procedure: Endovascular; Procedure: Surgery

• Registration Number: NCT06147102
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• All patients with an unruptured intracranial aneurysm undergoing treatment

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Exclusion Criteria

• Arteriovenous malformation related intracranial aneurysm
• Moyamoya-disease related intracranial aneurysm
• Ruptured intracranial aneurysm

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular treatment	Endovascular	Patients with unruptured intracranial aneurysms treated endovascularly
Surgical treatment	Surgery	Patients with unruptured intracranial aneurysms treated surgically

Primary Outcome Measures

Name	Time	Method
New ischemic lesion on postoperative MRI	1-3 days	Diffusion-Weighted Imaging lesion

Secondary Outcome Measures

Name	Time	Method
Neurological symptom	3 months	New procedure-related neurological symptom
Return to work	3 months	Days from intervention to return to work
Functional outcome	3 months	modified Rankin Scale (mRS going from 0 \[no sympyoms\] to 6 death\])
Aneurysm occlusion on angiography	6mo - 5yrs	Rate of occluded vs. incompletely occluded aneurysms. Assessed through digital subtraction angiography, CTA or MRA. Routine controls for endovascularly treated patients 6mo, 2y, and if needed 5y. Routinely assessed by a postoperative CTA for surgically treated patients.
Patients with late rebleeding from the target aneurysm	up to 10 yrs	Number of patients with rebleeding (subarachnoid hemorrhage \[SAH\]) from the treated aneurysm
Epilepsy	up to 10 yrs	Number of patients with a new diagnosis of epilepsy after aneurysm treatment
Dementia	up to 10 yrs	Number of patients with a new diagnosis of dementia after aneurysm treatment
Other stroke than aneurysm bleed	up to 10 yrs	Number of patients with a new stroke (other than SAH from the treated aneurysm) after aneurysm treatment

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Uusimaa, Finland