National Database of the Virtual Institute of Cerebrovascular Diseases

NCT ID: NCT05925699

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

285600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2052-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebrovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanitas Hospital, Italy

OTHER

Sponsor Role collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role collaborator

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role collaborator

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role collaborator

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role collaborator

Ospedale Pediatrico Bambin Gesù

OTHER

Sponsor Role collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role collaborator

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role collaborator

Istituto Neurologico Mediterraneo Neuromed S. R. L

OTHER

Sponsor Role collaborator

IRCCS San Raffaele Roma

OTHER

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role collaborator

Ospedale San Raffaele

OTHER

Sponsor Role collaborator

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role collaborator

Fondazione IRCCS San Gerardo dei Tintori

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Calabresi Paolo

Professor, Head of Neurology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy

Site Status

Countries

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Italy

Central Contacts

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Paolo Calabresi, Prof, MD

Role: CONTACT

+390630154459

Irene Scala

Role: CONTACT

+393519746393

Facility Contacts

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Paolo Calabresi, Prof, MD

Role: primary

+390630154459

Irene Scala, MD

Role: backup

+393519746393

References

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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.

Reference Type RESULT
PMID: 2326846 (View on PubMed)

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.

Reference Type RESULT
PMID: 35016208 (View on PubMed)

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.

Reference Type RESULT
PMID: 34487721 (View on PubMed)

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.

Reference Type RESULT
PMID: 21557809 (View on PubMed)

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.

Reference Type RESULT
PMID: 28552158 (View on PubMed)

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.

Reference Type RESULT
PMID: 31440838 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5832

Identifier Type: -

Identifier Source: org_study_id

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