HUIQE: The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06147102

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm	Procedure: Surgery Procedure: Endovascular

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Endovascular treatment Patients with unruptured intracranial aneurysms treated endovascularly	Procedure: Endovascular Endovascular treatment for the unruptured intracranial aneurysm
Surgical treatment Patients with unruptured intracranial aneurysms treated surgically	Procedure: Surgery Surgical treatment for the unruptured intracranial aneurysm

Arm

Intervention/Treatment

Endovascular treatment

Patients with unruptured intracranial aneurysms treated endovascularly

Procedure: Endovascular

Endovascular treatment for the unruptured intracranial aneurysm

Surgical treatment

Patients with unruptured intracranial aneurysms treated surgically

Procedure: Surgery

Surgical treatment for the unruptured intracranial aneurysm

Outcome Measures

Primary Outcome Measures

New ischemic lesion on postoperative MRI [1-3 days]
Diffusion-Weighted Imaging lesion

Secondary Outcome Measures

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