The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Study Overview
=================
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.

Official Title
-----------------
The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Procedure: Surgery
* Procedure: Endovascular


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with an unruptured intracranial aneurysm undergoing treatment Exclusion Criteria: Arteriovenous malformation related intracranial aneurysm Moyamoya-disease related intracranial aneurysm Ruptured intracranial aneurysm
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular treatment<br>Patients with unruptured intracranial aneurysms treated endovascularly | Procedure: Endovascular<br>* Endovascular treatment for the unruptured intracranial aneurysm<br>|
| Surgical treatment<br>Patients with unruptured intracranial aneurysms treated surgically | Procedure: Surgery<br>* Surgical treatment for the unruptured intracranial aneurysm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New ischemic lesion on postoperative MRI | Diffusion-Weighted Imaging lesion | 1-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological symptom | New procedure-related neurological symptom | 3 months | 
| Return to work | Days from intervention to return to work | 3 months | 
| Functional outcome | modified Rankin Scale (mRS going from 0 [no sympyoms] to 6 death]) | 3 months | 
| Aneurysm occlusion on angiography | 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. | 6mo - 5yrs | 
| Patients with late rebleeding from the target aneurysm | Number of patients with rebleeding (subarachnoid hemorrhage [SAH]) from the treated aneurysm | up to 10 yrs | 
| Epilepsy | Number of patients with a new diagnosis of epilepsy after aneurysm treatment | up to 10 yrs | 
| Dementia | Number of patients with a new diagnosis of dementia after aneurysm treatment | up to 10 yrs | 
| Other stroke than aneurysm bleed | Number of patients with a new stroke (other than SAH from the treated aneurysm) after aneurysm treatment | up to 10 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, intracranial aneurysm, neurosurgery, endovascular, interventional neuroradiology, neurointervention, unruptured