The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

NCT ID: NCT06147102

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endovascular treatment

Patients with unruptured intracranial aneurysms treated endovascularly

Endovascular

Intervention Type PROCEDURE

Endovascular treatment for the unruptured intracranial aneurysm

Surgical treatment

Patients with unruptured intracranial aneurysms treated surgically

Surgery

Intervention Type PROCEDURE

Surgical treatment for the unruptured intracranial aneurysm

Interventions

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Surgery

Surgical treatment for the unruptured intracranial aneurysm

Intervention Type PROCEDURE

Endovascular

Endovascular treatment for the unruptured intracranial aneurysm

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rahul Raj

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rahul Raj, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Hospital

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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HUS/216/2023

Identifier Type: -

Identifier Source: org_study_id

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