National Database of the Virtual Institute of Cerebrovascular Diseases (BIG-MENTI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebrovascular Disease
• Intervention / Treatment: Other: Collection of clinical, radiological, and biological data from patients' medical records

• Study Type: Observational
• Enrollment (Estimated): 285600

Contacts and Locations

• Study Contact: Name: Paolo Calabresi, Prof, MD; Phone Number: +390630154459; Email: paolo.calabresi@policlinicogemelli.it
• Study Contact Backup: Name: Irene Scala; Phone Number: +393519746393; Email: irene.scala01@icatt.it

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Contact: Paolo Calabresi, Prof, MD; Phone Number: +390630154459; Email: paolo.calabresi@policlinicogemelli.it
      • Contact: Irene Scala, MD; Phone Number: +393519746393; Email: irene.scala01@icatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.	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.	July 1, 2023 - July 1, 2053

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of clinical variables of each cerebrovascular disease correlated with its prognosis	Identification of the clinical variables of each cerebrovascular disease correlated with its prognosis	July 1, 2023 - July 1, 2053
Identification of radiological variables of each cerebrovascular disease correlated with its prognosis	Identification of the radiological variables of each cerebrovascular disease correlated with its prognosis	July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease correlated with its prognosis	Identification of the biomarkers of each cerebrovascular disease correlated with its prognosis	July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis	Identification of the neurophysiological variables of each cerebrovascular disease correlated with its prognosis	July 1, 2023 - July 1, 2053
Identification of prognostic scores for each cerebrovascular disease	Identification of prognostic scores for each cerebrovascular disease, based on the combination of clinical, radiological, neurophysiological and biomarker variables	July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease helping in differential diagnosis	Identification of clinical variables of each cerebrovascular disease that help the clinician in early differential diagnosis	July 1, 2023 - July 1, 2053
Identification of clinical variables of each cerebrovascular disease capable of predicting the development of complications	Identification of clinical variables of each cerebrovascular disease capable of predicting the development of spontaneous complications or complications related to therapeutic procedures	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 clinical variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies	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	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	July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease helping in differential diagnosis	Identification of neurophysiological variables and biomarkers 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 radiological variables of each cerebrovascular disease helping in differential diagnosis	July 1, 2023 - July 1, 2053
Identification of neurophysiological variables of each cerebrovascular disease capable of predicting the development of complications	Identification of neurophysiological 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 radiological variables of each cerebrovascular disease capable of predicting the development of complications	July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis	Identification of biomarkers of each cerebrovascular disease helping in differential diagnosis	July 1, 2023 - July 1, 2053
Identification of biomarkers of each cerebrovascular disease capable of predicting the development of complications	dentification of biomarkers of each cerebrovascular disease capable of predicting the development of complications	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 biomarkers 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 radiological variables of each cerebrovascular disease able to predict the success of pharmacological or procedural therapies	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 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 neurophysiological 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 biomarkers 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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Eur Heart J. 2022 Feb 04;:
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2052
• Study Completion (Estimated): September 1, 2052

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 5832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All the data collected in the registry will be available, upon reasonable request, for all the PIs and Sub-Is of the study of the various participating centers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No