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National Database of the Virtual Institute of Cerebrovascular Diseases

National Database of the Virtual Institute of Cerebrovascular Diseases

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05925699
Acronym
BIG-MENTI
Enrollment
285600
Registered
2023-06-29
Start date
2023-09-01
Completion date
2052-09-01
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disease

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.

Interventions

OTHERCollection of clinical, radiological, and biological data from patients' medical records

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER
Humanitas Hospital, Italy
CollaboratorOTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
CollaboratorOTHER
IRCCS National Neurological Institute C. Mondino Foundation
CollaboratorOTHER
I.R.C.C.S. Fondazione Santa Lucia
CollaboratorOTHER
Ospedale Policlinico San Martino
CollaboratorOTHER
IRCCS San Camillo, Venezia, Italy
CollaboratorOTHER
Istituto Di Ricerche Farmacologiche Mario Negri
CollaboratorOTHER
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
CollaboratorOTHER
Ospedale Pediatrico Bambin Gesù
CollaboratorOTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
CollaboratorOTHER
IRCCS Fondazione Stella Maris
CollaboratorOTHER
Istituto Neurologico Mediterraneo Neuromed S. R. L
CollaboratorOTHER
IRCCS San Raffaele Roma
CollaboratorOTHER
Fondazione Don Carlo Gnocchi Onlus
CollaboratorOTHER
Ospedale San Raffaele
CollaboratorOTHER
IRCCS Centro Neurolesi Bonino Pulejo
CollaboratorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
Istituto Auxologico Italiano
CollaboratorOTHER
Istituti Clinici Scientifici Maugeri SpA
CollaboratorOTHER
Fondazione IRCCS San Gerardo dei Tintori
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.July 1, 2023 - July 1, 2053Identification and definition of the various subtypes of each cerebrovascular disease (International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438) associated with poor prognosis.

Secondary

MeasureTime frameDescription
Identification of radiological variables of each cerebrovascular disease correlated with its prognosisJuly 1, 2023 - July 1, 2053Identification of the radiological variables of each cerebrovascular disease correlated with its prognosis
Identification of biomarkers of each cerebrovascular disease correlated with its prognosisJuly 1, 2023 - July 1, 2053Identification of the biomarkers of each cerebrovascular disease correlated with its prognosis
Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosisJuly 1, 2023 - July 1, 2053Identification of the neurophysiological variables of each cerebrovascular disease correlated with its prognosis
Identification of prognostic scores for each cerebrovascular diseaseJuly 1, 2023 - July 1, 2053Identification of prognostic scores for each cerebrovascular disease, based on the combination of clinical, radiological, neurophysiological and biomarker variables
Identification of clinical variables of each cerebrovascular disease helping in differential diagnosisJuly 1, 2023 - July 1, 2053Identification of clinical variables of each cerebrovascular disease that help the clinician in early differential diagnosis
Identification of clinical variables of each cerebrovascular disease capable of predicting the development of complicationsJuly 1, 2023 - July 1, 2053Identification of clinical variables of each cerebrovascular disease capable of predicting the development of spontaneous complications or complications related to therapeutic procedures
Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapiesJuly 1, 2023 - July 1, 2053Identification of clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Identification of the clinical variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcomeJuly 1, 2023 - July 1, 2053Identification of the clinical variables of each cerebrovascular disease useful for the purpose of personalizing the rehabilitation treatment and able to predict the good functional outcome following the same rehabilitation treatments
Identification of neurophysiological variables of each cerebrovascular disease helping in differential diagnosisJuly 1, 2023 - July 1, 2053Identification of neurophysiological variables and biomarkers of each cerebrovascular disease helping in differential diagnosis
Identification of clinical variables of each cerebrovascular disease correlated with its prognosisJuly 1, 2023 - July 1, 2053Identification of the clinical variables of each cerebrovascular disease correlated with its prognosis
Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complicationsJuly 1, 2023 - July 1, 2053Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications
Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complicationsJuly 1, 2023 - July 1, 2053Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications
Identification of biomarkers of each cerebrovascular disease helping in differential diagnosisJuly 1, 2023 - July 1, 2053Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis
Identification of biomarkers of each cerebrovascular disease capable of predicting the development of complicationsJuly 1, 2023 - July 1, 2053dentification of biomarkers of each cerebrovascular disease capable of predicting the development of complications
Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapiesJuly 1, 2023 - July 1, 2053Identification of biomarkers of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapiesJuly 1, 2023 - July 1, 2053Identification of radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies
Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcomeJuly 1, 2023 - July 1, 2053Identification of the radiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcomeJuly 1, 2023 - July 1, 2053Identification of the neurophysiological variables of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcomeJuly 1, 2023 - July 1, 2053Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Identification of radiological variables of each cerebrovascular disease helping in differential diagnosisJuly 1, 2023 - July 1, 2053Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis

Countries

Italy

Contacts

Primary ContactPaolo Calabresi, Prof, MD
paolo.calabresi@policlinicogemelli.it+390630154459
Backup ContactIrene Scala
irene.scala01@icatt.it+393519746393

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026