National Database of the Virtual Institute of Cerebrovascular Diseases

Overview

The primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. Secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases and the onset of complications related to therapeutic procedures, and to calculate predictive prognostic scores composed of multiple variables. Each participating center will collect clinical, radiological, and biological data from the medical records of the study participants. Patients included in the study will not undergo any additional medical procedures to those of normal clinical practice.

Interventions

• Other Collection of clinical, radiological, and biological data from patients' medical records
  Collection of clinical, radiological, and biological data from patients' medical records

Primary outcome measures

• Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis. [Time frame: July 1, 2023 - July 1, 2053]

Secondary outcome measures (12)

• Identification of clinical variables of each cerebrovascular disease correlated with its prognosis [Time frame: July 1, 2023 - July 1, 2053]
• Identification of radiological variables of each cerebrovascular disease correlated with its prognosis [Time frame: July 1, 2023 - July 1, 2053]
• Identification of biomarkers of each cerebrovascular disease correlated with its prognosis [Time frame: July 1, 2023 - July 1, 2053]
• Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis [Time frame: July 1, 2023 - July 1, 2053]
• Identification of prognostic scores for each cerebrovascular disease [Time frame: July 1, 2023 - July 1, 2053]
• Identification of clinical variables of each cerebrovascular disease helping in differential diagnosis [Time frame: July 1, 2023 - July 1, 2053]
• Identification of clinical variables of each cerebrovascular disease capable of predicting the development of complications [Time frame: July 1, 2023 - July 1, 2053]
• Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies [Time frame: July 1, 2023 - July 1, 2053]
• Identification of the clinical variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome [Time frame: July 1, 2023 - July 1, 2053]
• Identification of neurophysiological variables of each cerebrovascular disease helping in differential diagnosis [Time frame: July 1, 2023 - July 1, 2053]
• Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis [Time frame: July 1, 2023 - July 1, 2053]
• Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications [Time frame: July 1, 2023 - July 1, 2053]

Eligibility criteria

Inclusion criteria

• Diagnosis of cerebrovascular pathology defined according to the NINDS special report of 1990 as "all disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding and/or in which one or more blood vessels of the brain are mainly altered by a pathological process", falling within the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438;
• Informed consent provided by the patient or his legal representative in the case of mental incapacity or by the parents/guardians in the case of minors.

Exclusion criteria

• The patient, his legal representative in the case of mental incapacity or his parents/guardians in the case of minors clearly state their will to leave the study;
• Onset of cerebrovascular disease before January 1, 2016.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome

Publications

• Special report from the National Institute of Neurological Disorders and Stroke. Classification of cerebrovascular diseases III. Stroke. 1990 Apr;21(4):637-76. doi: 10.1161/01.str.21.4.637. No abstract available. PMID 2326846
• Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Soc PMID 35016208
• GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3. PMID 34487721
• Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x. PMID 21557809
• Ozpinar A, Mendez G, Abla AA. Epidemiology, genetics, pathophysiology, and prognostic classifications of cerebral arteriovenous malformations. Handb Clin Neurol. 2017;143:5-13. doi: 10.1016/B978-0-444-63640-9.00001-1. PMID 28552158
• Ferro JM, Aguiar de Sousa D. Cerebral Venous Thrombosis: an Update. Curr Neurol Neurosci Rep. 2019 Aug 23;19(10):74. doi: 10.1007/s11910-019-0988-x. PMID 31440838

Identifiers

NCT: NCT05925699 · 5832

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗