Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMontefiore Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Clipping
  • Endovascular embolization
  • Surveillance imaging

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Montefiore Medical Center

Lead sponsor

The Bee Foundation

Collaborator