Comprehensive Aneurysm Management (CAM): An All-Inclusive Care Trial for Unruptured Intracranial Aneurysms.

Disease Management Endpoint Determination Humans Intracranial Aneurysm / therapy Registries Research Design

Care trial Randomized trial Unruptured intracranial aneurysm

Journal

World neurosurgery

ISSN: 1878-8769

Titre abrégé: World Neurosurg

Pays: United States

ID NLM: 101528275

Informations de publication

Date de publication:
09 2020

Historique:

received: 15 04 2020

revised: 01 06 2020

accepted: 02 06 2020

pubmed: 12 6 2020

medline: 7 1 2021

entrez: 12 6 2020

Statut: ppublish

Résumé

In the absence of randomized evidence, the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain. Comprehensive Aneurysm Management (CAM) is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited, and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 to conservative or curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7 mm), location (anterior or posterior circulation), and age <60 years. The CAM primary outcome is survival without neurologic dependency (modified Rankin Scale [mRS] score <3) at 10 years. Secondary outcome measures include the incidence of subarachnoid hemorrhage during follow-up and related morbidity and mortality; morbidity and mortality related to endovascular treatment or surgical treatment of the UIA at 1 year; overall morbidity and mortality at 1, 5, and 10 years; when relevant, duration of hospitalization; and, when relevant, discharge to a location other than home. The primary hypothesis for patients randomly allocated to at least 2 options, 1 of which is conservative management, is that active UIA treatment will reduce the 10-year combined neurologic morbidity and mortality (mRS score >2) from 24% to 16%. At least 961 patients recruited from at least 20 centers over 4 years will be needed for the randomized portion of the study. Patients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.

Sections du résumé

BACKGROUND

In the absence of randomized evidence, the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain.

METHODS

Comprehensive Aneurysm Management (CAM) is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited, and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 to conservative or curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7 mm), location (anterior or posterior circulation), and age <60 years.

RESULTS

The CAM primary outcome is survival without neurologic dependency (modified Rankin Scale [mRS] score <3) at 10 years. Secondary outcome measures include the incidence of subarachnoid hemorrhage during follow-up and related morbidity and mortality; morbidity and mortality related to endovascular treatment or surgical treatment of the UIA at 1 year; overall morbidity and mortality at 1, 5, and 10 years; when relevant, duration of hospitalization; and, when relevant, discharge to a location other than home. The primary hypothesis for patients randomly allocated to at least 2 options, 1 of which is conservative management, is that active UIA treatment will reduce the 10-year combined neurologic morbidity and mortality (mRS score >2) from 24% to 16%. At least 961 patients recruited from at least 20 centers over 4 years will be needed for the randomized portion of the study.

CONCLUSIONS

Patients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.

Identifiants

DOI: 10.1016/j.wneu.2020.06.018 PMID: 32526362

pubmed: 32526362

pii: S1878-8750(20)31276-6

doi: 10.1016/j.wneu.2020.06.018

pii:

doi:

Types de publication

Clinical Trial Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

e770-e777