Clinical trial NCT06123325: Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)
Official title: Impact of Observation Versus Treatment on The Psychiatric and Mental Outcomes of Patients With Unruptured Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anxiety Depression
Aneurysm Cerebral
Mental Health Wellness 1
Keywords: Cerebral aneurysm
Anxiety
Depression
Endovascular
Clipping
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: The Bee Foundation
First posted: 2023-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients present to our outpatient clinic with unruptured intracranial aneurysms diagnosed on any of the angiographic imaging modalities including CTA, MRA, and Digital Subtraction Angiogram (DSA) and meet the eligibility criteria will be asked by a nurse practitioner or a research fellow to participate in the study.

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 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.

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/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.

Eligibility criteria: Inclusion Criteria:

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

  1. Specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms.
  2. 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 Criteria:

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

Primary outcomes:
measure: Anxiety
timeFrame: 6 months and 18 months
Secondary outcomes:
measure: Depression
timeFrame: 6 months and 18 months
measure: Aneurysm rupture
timeFrame: 6 months and 18 months
measure: Significant Aneurysm Growth
timeFrame: 6 months and 18 months
measure: Change in Neurologic Status
timeFrame: 6 months and 18 months
measure: Functional Outcome Status
timeFrame: 6 months and 18 months
measure: Acute adverse events
timeFrame: During admission
measure: Delayed adverse events
timeFrame: 3 months
measure: Procedure-related death
timeFrame: During admission
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Associate Professor at The Leo M. Davidoff Department of Neurological Surgery at Montefiore
name: David J Altschul, MD
role: PRINCIPAL_INVESTIGATOR
References: