Status:
RECRUITING
Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
The Bee Foundation
Conditions:
Anxiety Depression
Aneurysm Cerebral
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneur...
Detailed Description
This is a controlled, non-randomized, prospective cohort study with parallel arms of treatment arm with microsurgical and endovascular treatment and comparison control arm with conservative management...
Eligibility Criteria
Inclusion
- Unruptured intracranial aneurysms (UIA)
- mRS scores between 0-1
- Observation Group: All patients with UIAs that are eligible for conservative management
- Specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms
- Aneurysm size (largest dimension) is less than 4 mm
- Treatment Group: All patients with UIAs that are decided to be treated either with endovascular or microsurgical treatments due to several reasons, such as aneurysm size above 4 mm, patient's decision
Exclusion
- Prior history of Subarachnoid Hemorrhage (SAH)
- Prior history of intracranial aneurysm
- Severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases
- Traumatic, mycotic, dissecting, or fusiform aneurysms
- Patients with communication barriers (does not include foreign language), developmental disability, or psychiatric illness that prevent understanding of the questions required to complete assessments
- Patients with any physical disabilities or handicaps
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06123325
Start Date
December 1 2023
End Date
September 1 2027
Last Update
November 19 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467