- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07923084
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage (DECIPHER-pmSAH)
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage - A Prospective Observational Study
Background:
Perimesencephalic subarachnoid hemorrhage (pmSAH) is a distinct subtype of traumatic subarachnoid hemorrhage (SAH) characterized by a localized bleeding pattern around the midbrain not resulting from a ruptured aneurysm of a posterior circulation main artery. Traditionally considered benign with generally good prognosis, pmSAH has been attributed to a presumed venous etiology. However, recent advances in imaging technology have led to the identification of previously occult vascular lesions, most notably basilar artery perforator aneurysms (BAPAs) that may present a potential cause in a subset of patients with pmSAH. Preliminary data from the international PERFAN registry which retrospectively included 148 patients with ruptured BAPAs, challenge the benign perception of pmSAH as a whole. Interestingly, in this biggest case collection so far, patients diagnosed with BAPAs experienced significantly higher rates of complications and worse functional outcomes compared to cases of non-aneurysmal pmSAH (NA-pmSAH). To date, prospective data on prevalence, presentation and outcome of BAPA-associated pmSAH (BAPA-pmSAH) is missing, thus complicating decisions on management of this increasingly diagnosed entity.
Aims:
The DECIPHER-pmSAH study aims to establish a prospective registry to:
- determine and compare the prevalence of BAPA-pmSAH and non-aneurysmal pmSAH
- compare short-term and mid-term functional outcomes between patients with BAPA-pmSAH and those with non-aneurysmal pmSAH
- evaluate the rate and nature of complications in both these pmSAH subgroups
- enhance the understanding of radiological features associated with pmSAH, with the aim of distinguishing between BAPA-pmSAH and non-aneurysmal pmSAH
- characterize observed treatment strategies and their outcomes, comparing conservative and active management approaches
Design:
The DECIPHER-pmSAH is a prospective, multicenter, observational study. For an adequately powered study, we are aiming at enrollment of at least 264 patients over the course of three years, starting on January 1st, 2026. For recruiting participating sites, we are aiming to build upon the previously established collaboration with multiple international centers contributing to the PERFAN registry, in which cases of perforator aneurysms were retrospectively collected.
Methods:
This study will include cases of atraumatic pmSAH where no aneurysm of main arteries of the posterior circulation was detected. Predefined diagnostic workup criteria must be met for patient enrollment, including cross-sectional imaging (CT or MRI) at baseline, whenever possible and clinically justified at least one digital subtraction angiography (DSA) with high-resolution three-dimensional rotational angiography (3D-RA) and collection of clinical data at index presentation, hospital discharge and 90 days follow-up. Anonymized imaging data will be centrally analyzed by trained neuroradiologists, blinded to clinical data in a core lab at the Inselspital, Bern. The primary endpoint to be examined is the prevalence of ruptured BAPA and non-aneurysmal hemorrhage in cases of pmSAH. Secondary and tertiary endpoints include clinical outcomes at 90 days after index presentations and specific radiological findings respectively.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Tomas Dobrocky, MD
- Номер телефона: +41 31 632 13 77
- Электронная почта: tomas.dobrocky@insel.ch
Учебное резервное копирование контактов
- Имя: Luca Noti, MD
- Номер телефона: +41 31 632 70 00
- Электронная почта: luca.noti@insel.ch
Места учебы
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Bern, Швейцария, 3010
- Рекрутинг
- Inselspital, University Hospital Bern
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Главный следователь:
- Tomas Dobrocky, MD
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Контакт:
- Tomas Dobrocky, MD
- Номер телефона: +41 31 632 13 77
- Электронная почта: tomas.dobrocky@insel.ch
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Контакт:
- Luca Noti, MD
- Номер телефона: +41 31 632 70 00
- Электронная почта: luca.noti@insel.ch
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Младший исследователь:
- Luca Noti, MD
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Младший исследователь:
- Johann M Raabe, MD
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Младший исследователь:
- Bettina L Serrallach, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Patients from participating centers, diagnosed with a perimesencephalic subarachnoid hemorrhage (pmSAH) not resulting from a mechanical trauma or from a ruptured aneurysm of the main arteries of the posterior circulation (V4, Basilar trunk, basilar tip, AICA, PICA, PCA). Taking into account further exclusion criteria (see above), this leaves 2 possible etiologies for pmSAH: 1) basilar artery perforator aneurysms (BAPA); 2) "sine materia" = no vascular lesion could be identified as the source of the pmSAH
Описание
Inclusion Criteria:
- Patients aged ≥18 years with a non-traumatic pmSAH or limited additional blood in adjacent cisterns (pmSAH "plus")
- Cross-sectional imaging at baseline (CT or MRI)
- Written informed consent for study participation was obtained.
Exclusion Criteria:
- Presence of documented written or verbal refusal
- pmSAH patients with a presumed traumatic source
- Saccular/fusiform aneurysm of the main arteries of the posterior circulation (e.g. V4, AICA, PICA, basilar trunk, basilar tip)
- pmSAH patients with a shunting lesion in the vertebrobasilar territory (i.e. brain AVM, brain/spine AVF)
- pmSAH patients with a cavernous malformation in the posterior fossa
- Basilar artery perforator aneurysm group (BAPA group):
- Aneurysm arising from the basilar artery trunk adjacent to a perforating branch but not involving a perforating artery (Satti Type 1)
- Flow-related BAPA (i.e. AVM, AVF)
- Severely impaired renal function defined as KDIGO grade 4 (GFR <30 mL/min/1.73 m2)
- Pregnancy or suspected pregnancy
- Known adverse events to iodinated contrast media
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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All patients included in the study
The only study-specific intervention is the collection of a patient-reported outcome measure (PROM) in the form of the EQ-5D questionnaire at 3-month follow-up for all patients. All other analyzed data are collected as part of routine clinical care. |
The only study-specific intervention is the collection of a patient-reported outcome measure (PROM) in the form of the EQ-5D questionnaire at 3-month follow-up. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Rate of BAPAs in pmSAH where at least one high-resolution 3D-rotational angiography (3D-RA) of the dominant vertebral artery was performed within 7 days after the index presentation
Временное ограничение: Within 7 days after pmSAH diagnosis
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Within 7 days after pmSAH diagnosis
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Rate of patients with excellent functional outcome (Modified Rankin Scale 0-1) at 3 months
Временное ограничение: 3 months after enrollment
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3 months after enrollment
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Rate of patients with favorable functional outcome (Modified Rankin Scale 0-2) at 3 months
Временное ограничение: 3 months after enrollment
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3 months after enrollment
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Patient-Reported Outcome (EQ-5D-5L questionnaire) at 3 months
Временное ограничение: 3 months after enrollment
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3 months after enrollment
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Modified Rankin Scale (mRS, range 0-6 with higher scores indicating worse functional status) at hospital discharge
Временное ограничение: 21 days after enrollment or hospital discharge (if discharged earlier)
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21 days after enrollment or hospital discharge (if discharged earlier)
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National Institutes of Health Stroke Scale (NIHSS, range 0-42 with higher scores indicating greater neurological impairement) at hospital discharge
Временное ограничение: 21 days after enrollment or hospital discharge (if discharged earlier)
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21 days after enrollment or hospital discharge (if discharged earlier)
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Rate of rebleeding
Временное ограничение: From enrollment to 3-month follow-up
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From enrollment to 3-month follow-up
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Rate of hydrocephalus requiring EVD or lumbar drain
Временное ограничение: From enrollment to 3-month follow-up
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From enrollment to 3-month follow-up
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Rate of symptomatic vasospasm
Временное ограничение: From enrollment to 3-month follow-up
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From enrollment to 3-month follow-up
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Rate of BAPAs in pmSAH overall (regardless of 3D-RA acquisition)
Временное ограничение: From enrollment to 3-month follow-up
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From enrollment to 3-month follow-up
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Elsheikh S, Mohlenbruch M, Seker F, Berlis A, Maurer C, Kocer N, Jamous A, Behme D, Taschner C, Urbach H, Meckel S. Flow Diverter Treatment of Ruptured Basilar Artery Perforator Aneurysms : A Multicenter Experience. Clin Neuroradiol. 2022 Sep;32(3):783-789. doi: 10.1007/s00062-021-01133-y. Epub 2022 Jan 20.
- Granja MF, Monteiro A, Agnoletto GJ, Jamal S, Sauvageau E, Aghaebrahim A, Hanel R. A systematic review of non-trunk basilar perforator aneurysms: is it worth chasing the small fish? J Neurointerv Surg. 2020 Apr;12(4):412-416. doi: 10.1136/neurintsurg-2019-015311. Epub 2019 Oct 9.
- Lu GD, Zhao LB, Jia ZY, Liu S. Micro-guidewire electrocoagulation for the treatment of intracranial aneurysms that are inaccessible by microcatheterization: a case series and review of the literature. J Neurointerv Surg. 2023 Dec;15(12):1229-1233. doi: 10.1136/jnis-2022-019355. Epub 2022 Oct 25.
- Shlobin NA, Cantrell DR, Ansari SA, Hurley MC, Shaibani A, Jahromi BS, Potts MB. Conservative Management and Natural History of Ruptured Basilar Perforator Artery Aneurysms: Two Cases and Literature Review. World Neurosurg. 2020 Jun;138:218-222. doi: 10.1016/j.wneu.2020.03.042. Epub 2020 Mar 16.
- Kumagawa T, Otani N, Kakei Y, Negishi H, Suma T, Yoshino A. Ruptured Basilar Artery Perforator Aneurysm Definitely Diagnosed with Intraoperative Microsurgical Findings: Case Report and Literature Review. NMC Case Rep J. 2023 Jan 16;10:1-7. doi: 10.2176/jns-nmc.2022-0184. eCollection 2023.
- Rajbhandari S, Serrallach BL, Raabe JM, Piechowiak EI, Goldberg J, Seiffge DJ, Rentzos A, Zhu F, Scarcia L, Narata A, Amans MR, Premat K, Demerath T, Moehlenbruch M, Kumar R, Limbucci N, Piano M, Burel J, Bellanger G, Dorn F, Hennersdorf F, Stracke P, Milonia L, Cirillo L, Wasselius J, Lenthall R, Flynn L, Keston P, Raz E, Barvulsky E, Giubbolini F, Leonard-Lorant I, Smajda S, Klisch J, Kaiser DPO, Rizzuti M, Tanaka M, Kizilkilic O, Booth TC, Linfante I, Leber SL, Hassan F, Dumas V, Forestier G, Li Y, Alexandre A, Padilla-Palomo FJ, Karwacki GM, Saleem N, Abdalkader M, Herial NA, Pulli B, Tran CC, Raabe A, Gralla J, Bervini D, Z'Graggen WJ, Kaesmacher J, Dobrocky T; PERFAN registry (PERforator ANeurysm registry) collaborators. Differentiating aetiologies in perimesencephalic SAH: clinical insights into basilar artery perforator aneurysms. J Neurol Neurosurg Psychiatry. 2026 Jul 14:jnnp-2026-338621. doi: 10.1136/jnnp-2026-338621. Online ahead of print.
- Rouchaud A, Lehman VT, Murad MH, Burrows A, Cloft HJ, Lindell EP, Kallmes DF, Brinjikji W. Nonaneurysmal Perimesencephalic Hemorrhage Is Associated with Deep Cerebral Venous Drainage Anomalies: A Systematic Literature Review and Meta-Analysis. AJNR Am J Neuroradiol. 2016 Sep;37(9):1657-63. doi: 10.3174/ajnr.A4806. Epub 2016 May 12.
- Hou K, Yu J. Current status of perimesencephalic non-aneurysmal subarachnoid hemorrhage. Front Neurol. 2022 Sep 1;13:960702. doi: 10.3389/fneur.2022.960702. eCollection 2022.
- Rass V, Altmann K, Zamarian L, Lindner A, Kofler M, Gaasch M, Ianosi BA, Putnina L, Kindl P, Delazer M, Schiefecker AJ, Beer R, Pfausler B, Helbok R. Cognitive, Mental Health, Functional, and Quality of Life Outcomes 1 Year After Spontaneous Subarachnoid Hemorrhage: A Prospective Observational Study. Neurocrit Care. 2024 Aug;41(1):70-79. doi: 10.1007/s12028-023-01895-y. Epub 2023 Dec 21.
- Jung JY, Kim YB, Lee JW, Huh SK, Lee KC. Spontaneous subarachnoid haemorrhage with negative initial angiography: a review of 143 cases. J Clin Neurosci. 2006 Dec;13(10):1011-7. doi: 10.1016/j.jocn.2005.09.007. Epub 2006 Aug 23.
- Rinkel GJ, Wijdicks EF, Hasan D, Kienstra GE, Franke CL, Hageman LM, Vermeulen M, van Gijn J. Outcome in patients with subarachnoid haemorrhage and negative angiography according to pattern of haemorrhage on computed tomography. Lancet. 1991 Oct 19;338(8773):964-8. doi: 10.1016/0140-6736(91)91836-j.
- Mensing LA, Vergouwen MDI, Laban KG, Ruigrok YM, Velthuis BK, Algra A, Rinkel GJE. Perimesencephalic Hemorrhage: A Review of Epidemiology, Risk Factors, Presumed Cause, Clinical Course, and Outcome. Stroke. 2018 Jun;49(6):1363-1370. doi: 10.1161/STROKEAHA.117.019843. Epub 2018 Apr 25.
- Wallace AN, Vyhmeister R, Dines JN, Chatterjee AR, Kansagra AP, Viets R, Whisenant JT, Moran CJ, Cross DT 3rd, Derdeyn CP. Evaluation of an anatomic definition of non-aneurysmal perimesencephalic subarachnhoid hemorrhage. J Neurointerv Surg. 2016 Apr;8(4):378-85. doi: 10.1136/neurintsurg-2015-011680. Epub 2015 Mar 23.
- Rinkel GJ, Wijdicks EF, Vermeulen M, Ramos LM, Tanghe HL, Hasan D, Meiners LC, van Gijn J. Nonaneurysmal perimesencephalic subarachnoid hemorrhage: CT and MR patterns that differ from aneurysmal rupture. AJNR Am J Neuroradiol. 1991 Sep-Oct;12(5):829-34.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Цереброваскулярные расстройства
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Патологические процессы
- Кровотечение
- Внутричерепные кровоизлияния
- Патологические состояния, признаки и симптомы
- Субарахноидальное кровоизлияние
Другие идентификационные номера исследования
- CH-2025-01117
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .