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NCT Number: NCT06147102

The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital

Helsinki, Uusimaa, 00029 HUS, Finland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

Surgical treatment for the unruptured intracranial aneurysm

Endovascular

Procedure

Endovascular treatment for the unruptured intracranial aneurysm

Primary outcomes

  1. New ischemic lesion on postoperative MRI

    Time frame: 1-3 days

    Diffusion-Weighted Imaging lesion

Secondary outcomes

  1. Neurological symptom

    Time frame: 3 months

    New procedure-related neurological symptom

  2. Return to work

    Time frame: 3 months

    Days from intervention to return to work

  3. Functional outcome

    Time frame: 3 months

    modified Rankin Scale (mRS going from 0 [no sympyoms] to 6 death])

  4. Aneurysm occlusion on angiography

    Time frame: 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.

  5. Patients with late rebleeding from the target aneurysm

    Time frame: up to 10 yrs

    Number of patients with rebleeding (subarachnoid hemorrhage [SAH]) from the treated aneurysm

  6. Epilepsy

    Time frame: up to 10 yrs

    Number of patients with a new diagnosis of epilepsy after aneurysm treatment

  7. Dementia

    Time frame: up to 10 yrs

    Number of patients with a new diagnosis of dementia after aneurysm treatment

  8. Other stroke than aneurysm bleed

    Time frame: up to 10 yrs

    Number of patients with a new stroke (other than SAH from the treated aneurysm) after aneurysm treatment

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: HUIQE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 27, 2023
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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