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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

Cerebrovascular Disease

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

285,600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

285,600 participants in 1 patient group

All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049
Treatment:
Other: Collection of clinical, radiological, and biological data from patients' medical records

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Irene Scala; Paolo Calabresi, Prof, MD

Data sourced from clinicaltrials.gov

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