BIG-MENTI: National Database of the Virtual Institute of Cerebrovascular Diseases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049
|
Other: Collection of clinical, radiological, and biological data from patients' medical records
Collection of clinical, radiological, and biological data from patients' medical records
|
Outcome Measures
Primary Outcome Measures
- Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis. [July 1, 2023 - July 1, 2053]
Identification 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 Outcome Measures
- Identification of clinical variables of each cerebrovascular disease correlated with its prognosis [July 1, 2023 - July 1, 2053]
Identification of the clinical variables of each cerebrovascular disease correlated with its prognosis
- Identification of radiological variables of each cerebrovascular disease correlated with its prognosis [July 1, 2023 - July 1, 2053]
Identification of the radiological variables of each cerebrovascular disease correlated with its prognosis
- Identification of biomarkers of each cerebrovascular disease correlated with its prognosis [July 1, 2023 - July 1, 2053]
Identification of the biomarkers of each cerebrovascular disease correlated with its prognosis
- Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis [July 1, 2023 - July 1, 2053]
Identification of the neurophysiological variables of each cerebrovascular disease correlated with its prognosis
- Identification of prognostic scores for each cerebrovascular disease [July 1, 2023 - July 1, 2053]
Identification 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 diagnosis [July 1, 2023 - July 1, 2053]
Identification 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 complications [July 1, 2023 - July 1, 2053]
Identification 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 therapies [July 1, 2023 - July 1, 2053]
Identification 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 outcome [July 1, 2023 - July 1, 2053]
Identification 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 diagnosis [July 1, 2023 - July 1, 2053]
Identification of neurophysiological variables and biomarkers of each cerebrovascular disease helping in differential diagnosis
- Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis [July 1, 2023 - July 1, 2053]
Identification of radiological variables of each cerebrovascular disease helping in differential diagnosis
- Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications [July 1, 2023 - July 1, 2053]
Identification 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 complications [July 1, 2023 - July 1, 2053]
Identification of radiological variables of each cerebrovascular disease capable of predicting the development of complications
- Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis [July 1, 2023 - July 1, 2053]
Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis
- Identification of biomarkers of each cerebrovascular disease capable of predicting the development of complications [July 1, 2023 - July 1, 2053]
dentification 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 therapies [July 1, 2023 - July 1, 2053]
Identification 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 therapies [July 1, 2023 - July 1, 2053]
Identification 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 outcome [July 1, 2023 - July 1, 2053]
Identification 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 outcome [July 1, 2023 - July 1, 2053]
Identification 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 outcome [July 1, 2023 - July 1, 2053]
Identification of the biomarkers of each cerebrovascular disease useful for the personalization of the rehabilitation treatment and able to predict its functional outcome
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome | Lazio | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Humanitas Hospital, Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- IRCCS National Neurological Institute "C. Mondino" Foundation
- I.R.C.C.S. Fondazione Santa Lucia
- Ospedale Policlinico San Martino
- IRCCS San Camillo, Venezia, Italy
- Istituto di Ricerche Farmacologiche Mario Negri IRCCS
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Ospedale Pediatrico Bambin Gesù
- Fondazione IRCCS Policlinico San Matteo di Pavia
- IRCCS Fondazione Stella Maris
- Istituto Neurologico Mediterraneo Neuromed S. R. L
- IRCCS San Raffaele Roma
- Fondazione Don Carlo Gnocchi Onlus
- Ospedale San Raffaele
- IRCCS Centro Neurolesi "Bonino-Pulejo"
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Istituto Auxologico Italiano
- Istituti Clinici Scientifici Maugeri SpA
- Fondazione IRCCS San Gerardo dei Tintori
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 5832