Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Clipping
  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.
• Процедура Endovascular embolization
  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.
• Диагностический тест Surveillance imaging
  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 o

Первичные конечные точки

• Anxiety [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Anxiety [Срок оценки: 18 months]
• Depression [Срок оценки: 6 months and 18 months]
• Aneurysm rupture [Срок оценки: 6 months and 18 months]
• Significant Aneurysm Growth [Срок оценки: 6 months and 18 months]
• Change in Neurologic Status [Срок оценки: 6 months and 18 months]
• Functional Outcome Status [Срок оценки: 6 months and 18 months]
• Acute adverse events [Срок оценки: During admission]
• Delayed adverse events [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Montefiore Medical Center — The Bronx

Публикации

• Player MS, Peterson LE. Anxiety disorders, hypertension, and cardiovascular risk: a review. Int J Psychiatry Med. 2011;41(4):365-77. doi: 10.2190/PM.41.4.f. PMID 22238841
• Lemos M, Roman-Calderon JP, Calle G, Gomez-Hoyos JF, Jimenez CM. Personality and anxiety are related to health-related quality of life in unruptured intracranial aneurysm patients selected for non-intervention: A cross sectional study. PLoS One. 2020 Mar 12;15(3):e0229795. doi: 10.1371/journal.pone.0229795. eCollection 2020. PMID 32163437
• Hop JW, Rinkel GJ, Algra A, van Gijn J. Case-fatality rates and functional outcome after subarachnoid hemorrhage: a systematic review. Stroke. 1997 Mar;28(3):660-4. doi: 10.1161/01.str.28.3.660. PMID 9056628
• Hop JW, Rinkel GJ, Algra A, van Gijn J. Quality of life in patients and partners after aneurysmal subarachnoid hemorrhage. Stroke. 1998 Apr;29(4):798-804. doi: 10.1161/01.str.29.4.798. PMID 9550514
• Giordan E, Sorenson TJ, Brinjikji W, Vine R, Lanzino G. Risk factors for growth of conservatively managed unruptured intracranial aneurysms. Acta Neurochir (Wien). 2018 Dec;160(12):2419-2423. doi: 10.1007/s00701-018-3729-z. Epub 2018 Nov 11. PMID 30415386
• van der Schaaf IC, Brilstra EH, Rinkel GJ, Bossuyt PM, van Gijn J. Quality of life, anxiety, and depression in patients with an untreated intracranial aneurysm or arteriovenous malformation. Stroke. 2002 Feb;33(2):440-3. doi: 10.1161/hs0202.102335. PMID 11823649
• Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. doi: 10.1186/1477-7525-1-60. PMID 14613562
• Stern AF. The hospital anxiety and depression scale. Occup Med (Lond). 2014 Jul;64(5):393-4. doi: 10.1093/occmed/kqu024. No abstract available. PMID 25005549

Идентификаторы

NCT: NCT06123325 · 2023-15285

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗