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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05925699
Other study ID # 5832
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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