The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Intracranial Aneurysm Clinical Trial

— HUIQE  

Official title:

The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147102
• Other study ID #: HUS/216/2023
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: Helsinki University Central Hospital
• Contact: Rahul Raj, MD, PhD
• Phone: +358504272516
• Email: rahul.raj[@]hus.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Procedure:
• Surgery
Surgical treatment for the unruptured intracranial aneurysm
• Endovascular
Endovascular treatment for the unruptured intracranial aneurysm

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New ischemic lesion on postoperative MRI	Diffusion-Weighted Imaging lesion	1-3 days
Secondary	Neurological symptom	New procedure-related neurological symptom	3 months
Secondary	Return to work	Days from intervention to return to work	3 months
Secondary	Functional outcome	modified Rankin Scale (mRS going from 0 [no sympyoms] to 6 death])	3 months
Secondary	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
Secondary	Patients with late rebleeding from the target aneurysm	Number of patients with rebleeding (subarachnoid hemorrhage [SAH]) from the treated aneurysm	up to 10 yrs
Secondary	Epilepsy	Number of patients with a new diagnosis of epilepsy after aneurysm treatment	up to 10 yrs
Secondary	Dementia	Number of patients with a new diagnosis of dementia after aneurysm treatment	up to 10 yrs
Secondary	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