Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Anxiety Depression; Mental Health Wellness 1; Aneurysm Cerebral

Treatments: Procedure: Endovascular embolization; Diagnostic Test: Surveillance imaging; Procedure: Clipping

Study type: Interventional

Funder types: Other

Identifiers

NCT06123325

2023-15285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 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
• Patients with communication barriers (does not include foreign language), developmental disability, or psychiatric illness that prevent understanding of the questions required to complete assessments
• Patients with any physical disabilities or handicaps

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Treatment group

Experimental group

Description:

Patients with unruptured intracranial aneurysms, opting for active intervention undergo microsurgical clipping or endovascular therapy to preemptively secure the aneurysm and prevent rupture.

Treatment:

Procedure: Clipping

Procedure: Endovascular embolization

Observation group

Other group

Description:

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.

Treatment:

Diagnostic Test: Surveillance imaging