National Database of the Virtual Institute of Cerebrovascular Diseases

Cerebrovascular Disease Clinical Trial

— BIG-MENTI  

Official title:

National Database of the Virtual Institute of Cerebrovascular Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05925699
• Other study ID #: 5832
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2052

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Paolo Calabresi, Prof, MD
• Phone: +390630154459
• Email: paolo.calabresi[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 285600
• Est. completion date: September 1, 2052
• Est. primary completion date: September 1, 2052
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome	Lazio

Sponsors (21)

Lead Sponsor

Collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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, Bard — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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