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The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06147102
Acronym
HUIQE
Enrollment
173
Registered
2023-11-27
Start date
2023-01-01
Completion date
2027-12-31
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm

Keywords

intracranial aneurysm, surgery, neurosurgery, endovascular, interventional neuroradiology, neurointervention, unruptured

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.

Interventions

PROCEDURESurgery

Surgical treatment for the unruptured intracranial aneurysm

PROCEDUREEndovascular

Endovascular treatment for the unruptured intracranial aneurysm

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
New ischemic lesion on postoperative MRI1-3 daysDiffusion-Weighted Imaging lesion

Secondary

MeasureTime frameDescription
Return to work3 monthsDays from intervention to return to work
Functional outcome3 monthsmodified Rankin Scale (mRS going from 0 \[no sympyoms\] to 6 death\])
Aneurysm occlusion on angiography6mo - 5yrsRate 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.
Neurological symptom3 monthsNew procedure-related neurological symptom
Epilepsyup to 10 yrsNumber of patients with a new diagnosis of epilepsy after aneurysm treatment
Dementiaup to 10 yrsNumber of patients with a new diagnosis of dementia after aneurysm treatment
Other stroke than aneurysm bleedup to 10 yrsNumber of patients with a new stroke (other than SAH from the treated aneurysm) after aneurysm treatment
Patients with late rebleeding from the target aneurysmup to 10 yrsNumber of patients with rebleeding (subarachnoid hemorrhage \[SAH\]) from the treated aneurysm

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026