Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Phase

N/A

Condition

Aneurysm

Depression

Treatment

Clipping

Endovascular embolization

Surveillance imaging

Clinical Study ID

NCT06123325

2023-15285

Ages 18-75
All Genders

Study 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 aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Unruptured intracranial aneurysms (UIA)
mRS scores between 0-1
Observation Group: All patients with UIAs that are eligible for conservativemanagement.

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 withendovascular or microsurgical treatments due to several reasons, such as aneurysmsize above 4 mm, patient's decision.

Exclusion

Exclusion Criteria:

Prior history of intracranial hemorrhage.
Prior history of intracranial aneurysm
Severe comorbidities that impact the mental health of the patients, such severepsychiatric disease, and chronic end stage diseases.

Study Design

Clipping

December 01, 2023

March 31, 2026

Study 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/observation of UIA. The goal of this study is to investigate the impact of the awareness of an untreated UIA on the psychiatric and mental status of the patients enrolled in the control arm compared to patients with a treated UIA. All patients presenting to the outpatient clinic upon the initiation of the trial and for 2 years ahead with UIA diagnosed on any of the angiographic imaging modalities including Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), and Digital Subtraction Angiogram (DSA) will be included.

Connect with a study center

Montefiore Medical Center
Bronx, New York 10467
United States
Active - Recruiting

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