Cerebrovascular DiseaseBIG-MENTINCT06859502
National Database of the Virtual Institute of Cerebrovascular Diseases
An observational study of Cerebrovascular Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Disease
- How many people
- 312,800 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2024to 1 Apr 2054
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Don Gnocchi
Florence, FI, 50124
Cecchi, 3388627184, fcecchi@dongnocchi.it
About this study
Official title: "Registro Dati Nazionale Dell'Istituto Virtuale Delle Malattie Cerebrovascolari" "National Database of the Virtual Institute of Cerebrovascular Diseases"
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.
Read the detailed description
Considering the high incidence of cerebrovascular diseases, it therefore seems obvious how, in order to be able to demonstrate causal links and to search for prognostic factors with a high level of evidence, a systematic collection of large-scale data involving different facilities scattered throughout the country is necessary. Such systematic collection would allow both, as just mentioned, to obtain valid data on high-prevalence diseases, such as stroke, and to obtain sufficient evidence for the diagnostic and prognostic framing of those cerebrovascular diseases with lower incidence. In addition, considering the large amount of data, it seems clear that there is a need for a rapid and efficient information collection system that can guarantee an optimal result without overburdening the work of healthcare personnel. In this context, in 2017 the Ministry of Health established the IRCCS Network of Neuroscience and Neurorehabilitation (RIN).
Within this framework, numerous Virtual Institutes, specialized by disease areas, are being developed in a cross-cutting manner to provide the Network with its own strong identity, harmonize IRCCS activities, rationalize investments and resources, build large cohorts, and interact with international networks. To this end, a survey was sent to all Network members in October 2020 to indicate, in the specific area of Cerebrovascular Diseases: the human, infrastructural and technological resources available; and the volume and type of specific clinical activity carried out in the year 2019.
Thirty-two centers responded to the survey, expressing interest in the participation of the forming Virtual National Institute (IVN) of Cerebrovascular Diseases. The geographical distribution of participating centers is as follows: 22 in the North, 6 in the Center and 4 in the South. Peculiarities of this IVN are the high volume of patients with such frequent diseases, the great clinical specialization, the high technological level of care at all stages of the disease, and the required and necessary dynamism and timeliness of intervention.
The individual members of this IVN possess a great and diverse expertise in both care activities and clinical and pre-clinical research. In addition, considering the high sociomedical burden of the set of these pathologies, largely related to the permanent disability they entail, the IVN of Cerebrovascular Diseases will have the peculiarity of being able to follow the entire pathway of the Patient from the acute phases (hospital) to those of rehabilitation (in neurorehabilitation centers) until the return home. Through this study, the aim is to create a national registry for these diseases.
The primary objective of the study is to identify and define the various subtypes of each cerebrovascular disease falling under the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438, associated with poor prognosis.
Secondary objectives:
- Identification of clinical variables of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of biomarkers of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of the radiological variables of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of neurophysiological variables of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of prognostic scores for each cerebrovascular disease based on the combination of clinical, radiological, neurophysiological and biomarker variables;
- Identification of the clinical, radiological and neurophysiological variables and biomarkers of each cerebrovascular disease that will help the clinician in early differential diagnosis;
- Identifications of the clinical, radiological, and neurophysiological variables and biomarkers of each cerebrovascular pathology that can predict the development of spontaneous or procedure-related complications of treatment;
- Identifications of the clinical, radiological, and neurophysiological variables and biomarkers of each cerebrovascular pathology capable of predicting the successful outcome of pharmacological or procedural therapies;
- Identification of clinical, radiological, and neurophysiological variables and biomarkers of each cerebrovascular pathology useful for personalization of rehabilitation treatment and able to predict good functional outcome following the same rehabilitation treatments.
- Conditions
- Cerebrovascular Disease
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to maximum 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start10 Sep 2024
- Primary completion1 Apr 2053 (estimated)
- Study completion1 Apr 2054 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 312,800 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859502
- Sponsor's protocol ID
- BIG-MENTI
- Acronym
- BIG-MENTI
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Registro Dati Nazionale Dell'Istituto Virtuale Delle Malattie Cerebrovascolari" "National Database of the Virtual Institute of Cerebrovascular Diseases"
- ClinicalTrials.gov ID
- NCT06859502
- Acronym / sponsor ID
- BIG-MENTI / BIG-MENTI
- Conditions
- Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 312,800 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Apr 2053 (estimated)
- Study completion
- 1 Apr 2054 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Considering the high incidence of cerebrovascular diseases, it therefore seems obvious how, in order to be able to demonstrate causal links and to search for prognostic factors with a high level of evidence, a systematic collection of large-scale data involving different facilities scattered throughout the country is necessary. Such systematic collection would allow both, as just mentioned, to obtain valid data on high-prevalence diseases, such as stroke, and to obtain sufficient evidence for the diagnostic and prognostic framing of those cerebrovascular diseases with lower incidence. In addition, considering the large amount of data, it seems clear that there is a need for a rapid and efficient information collection system that can guarantee an optimal result without overburdening the work of healthcare personnel. In this context, in 2017 the Ministry of Health established the IRCCS Network of Neuroscience and Neurorehabilitation (RIN).
Within this framework, numerous Virtual Institutes, specialized by disease areas, are being developed in a cross-cutting manner to provide the Network with its own strong identity, harmonize IRCCS activities, rationalize investments and resources, build large cohorts, and interact with international networks. To this end, a survey was sent to all Network members in October 2020 to indicate, in the specific area of Cerebrovascular Diseases: the human, infrastructural and technological resources available; and the volume and type of specific clinical activity carried out in the year 2019.
Thirty-two centers responded to the survey, expressing interest in the participation of the forming Virtual National Institute (IVN) of Cerebrovascular Diseases. The geographical distribution of participating centers is as follows: 22 in the North, 6 in the Center and 4 in the South. Peculiarities of this IVN are the high volume of patients with such frequent diseases, the great clinical specialization, the high technological level of care at all stages of the disease, and the required and necessary dynamism and timeliness of intervention.
The individual members of this IVN possess a great and diverse expertise in both care activities and clinical and pre-clinical research. In addition, considering the high sociomedical burden of the set of these pathologies, largely related to the permanent disability they entail, the IVN of Cerebrovascular Diseases will have the peculiarity of being able to follow the entire pathway of the Patient from the acute phases (hospital) to those of rehabilitation (in neurorehabilitation centers) until the return home. Through this study, the aim is to create a national registry for these diseases.
The primary objective of the study is to identify and define the various subtypes of each cerebrovascular disease falling under the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438, associated with poor prognosis.
Secondary objectives:
- Identification of clinical variables of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of biomarkers of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of the radiological variables of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of neurophysiological variables of each cerebrovascular pathology correlated with the prognosis of the same;
- Identification of prognostic scores for each cerebrovascular disease based on the combination of clinical, radiological, neurophysiological and biomarker variables;
- Identification of the clinical, radiological and neurophysiological variables and biomarkers of each cerebrovascular disease that will help the clinician in early differential diagnosis;
- Identifications of the clinical, radiological, and neurophysiological variables and biomarkers of each cerebrovascular pathology that can predict the development of spontaneous or procedure-related complications of treatment;
- Identifications of the clinical, radiological, and neurophysiological variables and biomarkers of each cerebrovascular pathology capable of predicting the successful outcome of pharmacological or procedural therapies;
- Identification of clinical, radiological, and neurophysiological variables and biomarkers of each cerebrovascular pathology useful for personalization of rehabilitation treatment and able to predict good functional outcome following the same rehabilitation treatments.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome Measure
Time frame: From enrollment to maximum 1 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cecchi (3388627184, fcecchi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: From enrollment to maximum 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.