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Clinical Trials/NCT05925699
NCT05925699
Not yet recruiting
Not Applicable

National Database of the Virtual Institute of Cerebrovascular Diseases

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country285,600 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Disease
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
285600
Locations
1
Primary Endpoint
Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
September 1, 2052
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Calabresi Paolo

Professor, Head of Neurology Department

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • 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 neurophysiological variables of each cerebrovascular disease helping in differential diagnosis(July 1, 2023 - July 1, 2053)
  • Identification of clinical 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 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(July 1, 2023 - July 1, 2053)
  • 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(July 1, 2023 - July 1, 2053)
  • Identification of 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(July 1, 2023 - July 1, 2053)
  • Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis(July 1, 2023 - July 1, 2053)
  • Identification of prognostic scores for each cerebrovascular disease(July 1, 2023 - July 1, 2053)
  • Identification 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(July 1, 2023 - July 1, 2053)
  • Identification of biomarkers of each cerebrovascular disease correlated with its prognosis(July 1, 2023 - July 1, 2053)
  • Identification of clinical variables of each cerebrovascular disease helping in differential diagnosis(July 1, 2023 - July 1, 2053)
  • 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(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(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(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(July 1, 2023 - July 1, 2053)

Study Sites (1)

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