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NCT Number: NCT06123325

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

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.

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Key information

Conditions

Anxiety Depression Aneurysm Aneurysm Cerebral Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Intracranial Aneurysm Intracranial Arterial Diseases Mental Disorders Mental Health Wellness 1 Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

David J Altschul, MD

CONTACT

[email protected]

718-920-7498

David J Altschul, MD

PRINCIPAL_INVESTIGATOR

Muhammed Amir Essibayi, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Clipping

Procedure

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.

Endovascular embolization

Procedure

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.

Surveillance imaging

Diagnostic Test

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.

Primary outcomes

  1. Anxiety

    Time frame: 6 months

    The number of participants demonstrating anxiety will be determined using the Hospital Anxiety and Depression Scale (HADS) assessment tool. HADS is a widely used tool to evaluate anxiety and depression levels and is composed of 14 items in total, 7 items for anxiety and 7 for depression. The 7 anxiety subscale items are to be answered subjectively by patients using a four-point Likert scale (0-3) with a possible scoring range of 0-21 for anxiety. The number of participants with HADS scores of 8 and above will be considered to demonstrate positive signs of anxiety.

Secondary outcomes

  1. Anxiety

    Time frame: 18 months

    The number of participants demonstrating anxiety will be determined using the Hospital Anxiety and Depression Scale (HADS) assessment tool. HADS is a widely used tool to evaluate anxiety and depression levels and is composed of 14 items in total, 7 items for anxiety and 7 for depression. The 7 anxiety subscale items are to be answered subjectively by patients using a four-point Likert scale (0-3) with a possible scoring range of 0-21 for anxiety. The number of participants with HADS scores of 8 and above will be considered to demonstrate positive signs of anxiety.

  2. Depression

    Time frame: 6 months and 18 months

    The number of participants demonstrating depression will be determined using the Hospital Anxiety and Depression Scale (HADS) assessment tool. HADS is a widely used tool to evaluate anxiety and depression levels and is composed of 14 items in total, 7 items for anxiety and 7 for depression. The 7 depression subscale items are to be answered subjectively by patients using a four-point Likert scale (0-3) with a possible scoring range of 0-21 for depression. The number of participants with HADS scores of 8 and above will be considered to demonstrate positive signs of depression.

  3. Aneurysm rupture

    Time frame: 6 months and 18 months

    The number of participants with any recorded event of aneurysm rupture during the follow-up periods of observed or treated Unruptured Intracranial Aneurysm (UIA) will be determined.

  4. Significant Aneurysm Growth

    Time frame: 6 months and 18 months

    The number of participants demonstrating significant aneurysm growth during the follow-up periods will be determined. Significant aneurysm growth is defined as any aneurysm growth of >= 3 millimeters of observed or treated UIA.

  5. Change in Neurologic Status

    Time frame: 6 months and 18 months

    The number of participants with change in neurologic status will be determined using the National Institute of Health (NIH) Stroke Scale/Score (NIHSS). The NIHSS is a 15-item neurological examination with each item scored on a 3- to 5-point scale, with 0 as normal. Scores range from 0-42 and there is an allowance for untestable items. Progressive increase in NIHSS score by 2 or more points after the procedure and through study completion will be considered as a bad outcome.

  6. Functional Outcome Status

    Time frame: 6 months and 18 months

    The number of participants demonstrating favorable functional outcome status will be assessed using a modified Rankin Scale (mRS) score. Participants with scores ranging from 0 (no disability) to 2 (slight disability) will be considered to have a favorable functional outcome status. Participants with mRS scores ranging from 3 (Moderate disability) to 5 (severe disability) will be considered to have an unfavorable functional outcome status.

  7. Acute adverse events

    Time frame: During admission

    The number of acute adverse events during hospital admission will be tabulated. Acute adverse events will encompass management and procedure-related complications. Increased incidence of procedure-related complications portends more unfavorable outcomes.

  8. Delayed adverse events

    Time frame: 3 months

    The number of delayed adverse events will be tabulated. Delayed adverse events will encompass management and procedure-related complications. Increased incidence of procedure-related complications portends more unfavorable outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Genesis Liriano, MD

CONTACT

[email protected]

718-920-2469

Muhammed Amir Essibayi, MD

CONTACT

[email protected]

718-920-7498

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • The Bee Foundation

Registry information

Official study title

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

Acronym: POUIA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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