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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Muhammed Amir Essibayi, MD
muhammedamir.essibayi@einsteinmed.edu
718-920-7498
Backup
Genesis Liriano, MD
gliriano@montefiore.org
718-920-2469
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 120
Treatments
Experimental: Treatment group
Patients with unruptured intracranial aneurysms, opting for active intervention undergo microsurgical clipping or endovascular therapy to preemptively secure the aneurysm and prevent rupture.
Other: Observation group
Patients with unruptured intracranial aneurysms, opting for conservative management undergo regular monitoring with serial imaging to track aneurysm stability, deferring interventional treatment unless changes indicate an increased risk of rupture.
Related Therapeutic Areas
Sponsors
Collaborators: The Bee Foundation
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov

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