Clinical trial NCT05925699: National Database of the Virtual Institute of Cerebrovascular Diseases
Official title: National Database of the Virtual Institute of Cerebrovascular Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebrovascular Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Humanitas Hospital, Italy
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: I.R.C.C.S. Fondazione Santa Lucia
name: Ospedale Policlinico San Martino
name: IRCCS San Camillo, Venezia, Italy
name: Istituto Di Ricerche Farmacologiche Mario Negri
name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: Ospedale Pediatrico Bambin Gesù
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: IRCCS Fondazione Stella Maris
name: Istituto Neurologico Mediterraneo Neuromed S. R. L
name: IRCCS San Raffaele Roma
name: Fondazione Don Carlo Gnocchi Onlus
name: Ospedale San Raffaele
name: IRCCS Centro Neurolesi Bonino Pulejo
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Istituto Auxologico Italiano
name: Istituti Clinici Scientifici Maugeri SpA
name: Fondazione IRCCS San Gerardo dei Tintori
First posted: 2023-06-29
Enrollment: 285600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with cerebrovascular diseases occuring between January 1, 2016 and July 1, 2049 who consented to partecipate in the study

Brief summary: 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.


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.

Primary outcomes:
measure: Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.
timeFrame: July 1, 2023 - July 1, 2053
Secondary outcomes:
measure: Identification of clinical variables of each cerebrovascular disease correlated with its prognosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of radiological variables of each cerebrovascular disease correlated with its prognosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of biomarkers of each cerebrovascular disease correlated with its prognosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of prognostic scores for each cerebrovascular disease
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of clinical variables of each cerebrovascular disease helping in differential diagnosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of clinical variables of each cerebrovascular disease capable of predicting the development of complications
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of the clinical variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of neurophysiological variables of each cerebrovascular disease helping in differential diagnosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of biomarkers of each cerebrovascular disease capable of predicting the development of complications
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
timeFrame: July 1, 2023 - July 1, 2053
measure: Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
timeFrame: July 1, 2023 - July 1, 2053
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: Lazio
Study officials:
References:
citation: 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.
citation: 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 Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.
citation: 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.
citation: 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.
citation: 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.
citation: 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.