The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study (HUIQE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Procedure: Endovascular; Procedure: Surgery

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029 HUS
      • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing endovascular or surgical treatment for an unruptured intracranial aneurysm at Helsinki university hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Rahul Raj, MD, PhD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: surgery; endovascular; neurosurgery; intracranial aneurysm; unruptured; interventional neuroradiology; neurointervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: HUS/216/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing regulated by the Secondary Use of Health And Social Data Act in Finland.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No