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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05925699

Recruitment Status : Not yet recruiting

First Posted : June 29, 2023

Last Update Posted : July 13, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

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

Information provided by (Responsible Party):

Calabresi Paolo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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
Cerebrovascular Disease	Other: Collection of clinical, radiological, and biological data from patients' medical records

Study Design

Layout table for study information

Study Type :	Observational [Patient Registry]
Estimated Enrollment :	285600 participants
Observational Model:	Cohort
Time Perspective:	Other
Target Follow-Up Duration:	3 Years
Official Title:	National Database of the Virtual Institute of Cerebrovascular Diseases
Estimated Study Start Date :	September 1, 2023
Estimated Primary Completion Date :	September 1, 2052
Estimated Study Completion Date :	September 1, 2052

Groups and Cohorts

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

Outcome Measures

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 ]
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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
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 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05925699

Contacts

Layout table for location contacts

Contact: Paolo Calabresi, Prof, MD	+390630154459	paolo.calabresi@policlinicogemelli.it
Contact: Irene Scala	+393519746393	irene.scala01@icatt.it

Locations

Layout table for location information

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

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

Study Documents (Full-Text)

Documents provided by Calabresi Paolo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:

Study Protocol and Statistical Analysis Plan [PDF] May 11, 2023

More Information

Publications of Results:

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;:

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.

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.

Layout table for additonal information

Responsible Party:	Calabresi Paolo, Professor, Head of Neurology Department, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:	NCT05925699
Other Study ID Numbers:	5832
First Posted:	June 29, 2023 Key Record Dates
Last Update Posted:	July 13, 2023
Last Verified:	July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
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

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

To Top