National Database of the Virtual Institute of Cerebrovascular Diseases

NCT06859502 | Recruiting

• 1 other identifier: BIG-MENTI
• Study Type: observational
• Target: 312,800
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the study is to identify prognostic predictors of cerebrovascular disease during various stages of the cerebrovascular disease itself, namely: hospitalization at the acute care facility, residential hospitalization at neurorehabilitation facilities, outpatient follow-up visits, and day hospital admissions at the various facilities. The aim is to obtain data on those factors that can influence the prognosis, thus the clinical outcome, of patients with cerebrovascular disease. Cerebrovascular diseases are defined by the World Health Organization (WHO) as "all those disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding or in which one or more cerebral blood vessels are primarily affected in a pathological process, or a combination of the two conditions mentioned above." These diseases include a wide range of conditions, of which ischemic stroke and cerebral hemorrhage are the most common. Given the high overall frequency of these diseases and, consequently, the high social and economic cost of them on the population, it is essential to recognize as soon as possible those factors capable of predicting the time course of patients affected, as you are, by these diseases, also with a view to identifying strategies to improve the prognosis of patients for whom an unfavorable outcome is predicted. In addition, given the high prevalence of cerebrovascular disease, it is necessary that an extremely large patient population be enrolled, and thus an enormous amount of data be collected, in order for meaningful results to be obtained. The primary objective of this study is, in fact, to collect a large amount of clinical data, i.e., to establish a national data registry, obtained from the records of patients with cerebrovascular diseases that began after January 1, 2016, in order to be able to identify and define the subtypes of each cerebrovascular disease associated with poor prognosis. The secondary objectives are to identify clinical, neurophysiological, radiological, and biomarker data that are able to predict the clinical course of cerebrovascular disease over time and to identify prognostic scores obtained from the combination of the variables first indicated. With this study, we also aim to identify those clinical, radiological, and neurophysiological data that are able to help the clinician in the early differential diagnosis of these diseases and that are able to predict the occurrence of spontaneous or procedure-related complications and the successful outcome of treatment. Finally, we aim to identify those clinical, radiological, and neurophysiological variables that are able to predict a good outcome of rehabilitation performed as a result of the onset of cerebrovascular disease.

Conditions

Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Identification and definition of the various subtypes of each cerebrovascular disease, falling under the following International Classification of Diseases, 9th revision (ICD-9) codes: ICD-9 430-438, associated with poor prognosis.

  From enrollment to maximum 1 month

Study Arms (1)

Patients with cerebrovascular diseases

Participants will be recruited at any stage of cerebrovascular disease management: acute hospitalization, subsequent neuromotor rehabilitation, or follow-up outpatient visit three months after the acute event.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at each individual center by the principal investigator (PI) or one of the local sub-investigators (sub-I) at any stage of cerebrovascular disease management: acute hospitalization, subsequent neuromotor rehabilitation, or follow-up outpatient visit three months after the acute event.

You may qualify if:

• Diagnosis of cerebrovascular pathology defined according to the 1990 NINDS special report2 as "all disorders in which an area of the brain is transiently or permanently affected by ischemia or bleeding and/or in which one or more of the blood vessels of the brain are primarily altered by a pathological process," falling under the following International Classification of Diseases, 9th revision (ICD-9) codes: ICD-9 430-438;
• Informed consent provided by the patient or the patient's legal representative in the case of incapacitation, or by the parents/guardians in the case of minor subjects.

You may not qualify if:

• The patient, his or her legal representative in the case of incapacitation, or his or her parents/guardians in the case of minor subjects irrefutably express the will to leave the study;
• Onset of cerebrovascular disease before January 1, 2016.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

IRCCS Don Gnocchi

Florence, FI, 50124, Italy

RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Francesca Cecchi

CONTACT

3388627184; fcecchi@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: September 10, 2024
• Primary Completion (Estimated): April 1, 2053
• Study Completion (Estimated): April 1, 2054
• Last Updated: March 5, 2025

Record last verified: 2024-04

Locations

IT (1)