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RECRUITING
NCT06123325
NA

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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.

Official title: Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-12-01

Completion Date

2027-09

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

PROCEDURE

Clipping

Microsurgical clipping of intracranial aneurysms involves craniotomy to access the brain, locating the aneurysm, and placing a small metal clip across its neck, thereby isolating it from normal blood circulation to prevent rupture.

PROCEDURE

Endovascular embolization

Any endovascular embolization of intracranial aneurysms that involves navigating microcatheters through the vascular system to the site of the aneurysm and deploying materials like coils, flow-diverting stents, or endosaccular flow disruptors to occlude the aneurysm and reduce the risk of rupture.

DIAGNOSTIC_TEST

Surveillance imaging

Surveillance imaging for brain aneurysms is a diagnostic approach that uses imaging techniques such as MRI, MRA, CTA, or DSA to regularly monitor the status of detected brain aneurysms. The goal is to track changes in the aneurysm's size, shape, or structure over time, which may indicate an increased risk of rupture. This ongoing assessment helps healthcare providers decide whether to continue monitoring or to consider treatment options, such as surgical clipping or endovascular coiling, based on the aneurysm's characteristics and the patient's risk factors.

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States