Cerebral InfarctionICDIM 1NCT04802772
Construction of a Multidimensional Score for the Functional Prognosis of Cerebral Infarctions
An observational study of Cerebral Infarction, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
In France, stroke is the leading cause of non-traumatic acquired motor disability in adults, the second leading cause of major cognitive impairment, and the third leading cause of death in men and women. The average age of onset is 73 years (70 years for men, 76 years for women). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction
- How many people
- 2,091 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients hospitalized in the Neurology-Neurovascular department of GHPSJ and discharged from hospitalization between January 1, 2016 and September 25, 2020.
Who may be able to join
- Major patients hospitalized in the Neurology-Neurovascular department of GHPSJ and discharged from hospital between January 1, 2016 and September 25, 2020.
- Main diagnosis (MD) of CI retained by the MISP (Medicalization of Information Systems Program) grouping algorithm for the SSS (Standardized summary of stay) and defined according to the codes of the chapter "Cerebral Infarction": I63.0 to I63.5 and I63.7 to I63.9 of the ICD-10 (International Classification of Diseases, 10th revision)
- Patients hospitalized in the NICU and for whom the passage to the NICU is the first hospitalization unit from their home or the hospitalization unit that follows a passage to the emergency department/ emergency door beds/short-term hospitalization unit (STHU)
- Length of stay greater than or equal to 3 nights
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of his/her data for this research
- SSS with MD I63.6 (CI due to cerebral venous thrombosis, non-pyogenic)
- Length of stay less than or equal to 2 nights
Show all 9Show fewer
- Patients from other GHPSJ hospitalization units (excluding emergency department emergency, emergency door beds or STHU), or from an external establishment
- SSS with a MD I63.0 to I63.5 or I63.7 to I63.9 not involving a passage in the NICU
- SSS with a MD I63.0 to I63.5 or I63.7 to I63.9 involving a visit to a NICU that is neither the first hospitalization unit from home nor the hospitalization unit that follows a visit to the emergency department / emergency door beds/short-term hospitalization unit
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
In France, stroke is the leading cause of non-traumatic acquired motor disability in adults, the second leading cause of major cognitive impairment, and the third leading cause of death in men and women. The average age of onset is 73 years (70 years for men, 76 years for women). All types combined, approximately 100,000 patients are hospitalized for stroke each year, approximately 40,000 people die and 30,000 have serious after-effects at one year. The spectrum of functional sequelae ranges from motor and sensory impairment to cognitive impairment; moreover, 30 to 50% of patients have a recurrence within 5 years.
Data from the Dijon Stroke Registry showed in 2011 that only 36% of people who had a stroke between 2000 and 2009 were symptom-free 1 month after the event; 22% of patients had mild or moderate disability according to the modified Rankin Scale (mRS); and 42% were unable to walk without assistance or had died. Based on 2009 self-reported data, more than one in two (51%) of those with a history of stroke with sequelae reported significant difficulty or inability to walk 500 meters; 45% had difficulty with at least one activity of daily living. The mortality rate was 44.7 per 100 000 persons in 2013.
Cerebral infarctions (CIs) account for the majority of strokes (70-75%). In 2014, despite a 12.5% decrease from 2008, hospital case fatality for CIs remained high at 9%. In 2015, the case fatality rate was 10.7% at 30 days and 11.9% at 1 year. Thirty-day mortality alone concentrated nearly half (47%) of the 1-year mortality.
Read the detailed description
Data regarding the validity of poor prognostic criteria for CI are still scarce and remain of imperfect quality, particularly because of heterogeneous populations and variable definitions of "poor prognosis." Prognostic assessment must take into account both neurological and non-neurological elements. Biomarkers have been one of the avenues explored for several years. For example, hyperglycemia in the acute phase of CI is associated with a more severe prognosis in terms of survival and functional recovery, and with an increased risk of bleeding after thrombolysis, independently of age and severity of the CI. Other biological markers have been studied, but the methodology of the studies is very variable and their quality is moderate, which does not allow us to conclude that these markers are independent predictive factors for the prognosis of CI. Their predictive "added value" on simple clinical data, such as the National Institutes of Health Stroke Scale (NHISS) severity score and age, has not been established and their clinical significance remains uncertain.
The mRS 3 months after the event is the criterion most frequently used to assess the functional prognosis of patients after a heart attack. However, being able to anticipate the mRS at discharge from hospital, as early as admission, appears to be a major challenge in order to adapt therapies and to choose the best care pathway as soon as possible after hospitalization. Structured management of stroke in neurovascular units (UNV), with highly specialized medical and paramedical staff, has a proven benefit in preventing death and dependence. The era of "precision" medicine, based on the identification, evaluation, organization and analysis of a multitude of variables obtained for each individual, now holds great potential for the management of CI.
The deployment of a computerized patient record (CPR) in health care institutions is a real opportunity in this respect. The detailed medical data collected from the moment the patient enters the hospital and throughout his or her hospitalization could be used to construct a composite score combining information from the patient's history, clinical data, and the results of additional examinations (especially biological and imaging). Beyond structured data, information expressed in textual form could also be considered using innovative artificial intelligence methodologies.
A neurovascular intensive care unit (NICU), to which a neurovascular unit (NVU) is attached, has existed within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) since 2006. The institution currently counts more than 700 stays per year for IC management, a figure that is constantly increasing (600 in 2016, 727 in 2019); 98% of these patients made a passage in the USINV in 2019. In addition, the CIO was deployed from 2014 in the facility, and during 2015 specifically for the Neurology-Neurovascular service. This gives the facility the opportunity to conduct a single-center pilot study to test the contribution of new data, combined with the simple clinical data usually used, to assess the functional prognosis of patients with CI.
The objective of this first retrospective work is to evaluate the interest of the data available in the CIO and their processing via artificial intelligence methods to characterize the functional prognosis of patients with a CI, at admission and then during hospitalization.
- Conditions
- Cerebral Infarction
- Keywords
- multidimensional score
- Medical subject headings
- Cerebral Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
To construct a multidimensional ICDIM 1 score predictive of the functional prognosis of patients at discharge from a hospitalization motivated by a CI
Comparison of observed correlations between ICDIM 1 and the change in mRS score before hospitalization and its value assessed at discharge adjusted for length of stay
Measured: Up to 6 months
Compare the performance of the artificial intelligence-based ICDIM 1 score with the performance of the NIHSS reference score
Comparison of the observed correlations between the NHISS score and this same change in the mRS score
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start30 Apr 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,091 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie BOURSIER, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802772
- Sponsor's protocol ID
- ICDIM 1
- Acronym
- ICDIM 1
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Multidimensional Score for the Functional Prognosis of Cerebral Infarctions
- ClinicalTrials.gov ID
- NCT04802772
- Acronym / sponsor ID
- ICDIM 1 / ICDIM 1
- Conditions
- Cerebral Infarction
- Keywords
- multidimensional score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,091 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Mar 2021 (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.
In France, stroke is the leading cause of non-traumatic acquired motor disability in adults, the second leading cause of major cognitive impairment, and the third leading cause of death in men and women. The average age of onset is 73 years (70 years for men, 76 years for women). All types combined, approximately 100,000 patients are hospitalized for stroke each year, approximately 40,000 people die and 30,000 have serious after-effects at one year. The spectrum of functional sequelae ranges from motor and sensory impairment to cognitive impairment; moreover, 30 to 50% of patients have a recurrence within 5 years.
Data from the Dijon Stroke Registry showed in 2011 that only 36% of people who had a stroke between 2000 and 2009 were symptom-free 1 month after the event; 22% of patients had mild or moderate disability according to the modified Rankin Scale (mRS); and 42% were unable to walk without assistance or had died. Based on 2009 self-reported data, more than one in two (51%) of those with a history of stroke with sequelae reported significant difficulty or inability to walk 500 meters; 45% had difficulty with at least one activity of daily living. The mortality rate was 44.7 per 100 000 persons in 2013.
Cerebral infarctions (CIs) account for the majority of strokes (70-75%). In 2014, despite a 12.5% decrease from 2008, hospital case fatality for CIs remained high at 9%. In 2015, the case fatality rate was 10.7% at 30 days and 11.9% at 1 year. Thirty-day mortality alone concentrated nearly half (47%) of the 1-year mortality.
Detailed description
Data regarding the validity of poor prognostic criteria for CI are still scarce and remain of imperfect quality, particularly because of heterogeneous populations and variable definitions of "poor prognosis." Prognostic assessment must take into account both neurological and non-neurological elements. Biomarkers have been one of the avenues explored for several years. For example, hyperglycemia in the acute phase of CI is associated with a more severe prognosis in terms of survival and functional recovery, and with an increased risk of bleeding after thrombolysis, independently of age and severity of the CI. Other biological markers have been studied, but the methodology of the studies is very variable and their quality is moderate, which does not allow us to conclude that these markers are independent predictive factors for the prognosis of CI. Their predictive "added value" on simple clinical data, such as the National Institutes of Health Stroke Scale (NHISS) severity score and age, has not been established and their clinical significance remains uncertain.
The mRS 3 months after the event is the criterion most frequently used to assess the functional prognosis of patients after a heart attack. However, being able to anticipate the mRS at discharge from hospital, as early as admission, appears to be a major challenge in order to adapt therapies and to choose the best care pathway as soon as possible after hospitalization. Structured management of stroke in neurovascular units (UNV), with highly specialized medical and paramedical staff, has a proven benefit in preventing death and dependence. The era of "precision" medicine, based on the identification, evaluation, organization and analysis of a multitude of variables obtained for each individual, now holds great potential for the management of CI.
The deployment of a computerized patient record (CPR) in health care institutions is a real opportunity in this respect. The detailed medical data collected from the moment the patient enters the hospital and throughout his or her hospitalization could be used to construct a composite score combining information from the patient's history, clinical data, and the results of additional examinations (especially biological and imaging). Beyond structured data, information expressed in textual form could also be considered using innovative artificial intelligence methodologies.
A neurovascular intensive care unit (NICU), to which a neurovascular unit (NVU) is attached, has existed within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) since 2006. The institution currently counts more than 700 stays per year for IC management, a figure that is constantly increasing (600 in 2016, 727 in 2019); 98% of these patients made a passage in the USINV in 2019. In addition, the CIO was deployed from 2014 in the facility, and during 2015 specifically for the Neurology-Neurovascular service. This gives the facility the opportunity to conduct a single-center pilot study to test the contribution of new data, combined with the simple clinical data usually used, to assess the functional prognosis of patients with CI.
The objective of this first retrospective work is to evaluate the interest of the data available in the CIO and their processing via artificial intelligence methods to characterize the functional prognosis of patients with a CI, at admission and then during hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients hospitalized in the Neurology-Neurovascular department of GHPSJ and discharged from hospitalization between January 1, 2016 and September 25, 2020.
Key inclusion criteria (4 listed)
- Major patients hospitalized in the Neurology-Neurovascular department of GHPSJ and discharged from hospital between January 1, 2016 and September 25, 2020.
- Main diagnosis (MD) of CI retained by the MISP (Medicalization of Information Systems Program) grouping algorithm for the SSS (Standardized summary of stay) and defined according to the codes of the chapter "Cerebral Infarction": I63.0 to I63.5 and I63.7 to I63.9 of the ICD-10 (International Classification of Diseases, 10th revision)
- Patients hospitalized in the NICU and for whom the passage to the NICU is the first hospitalization unit from their home or the hospitalization unit that follows a passage to the emergency department/ emergency door beds/short-term hospitalization unit (STHU)
- Length of stay greater than or equal to 3 nights
Key exclusion criteria (9 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of his/her data for this research
- SSS with MD I63.6 (CI due to cerebral venous thrombosis, non-pyogenic)
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
To construct a multidimensional ICDIM 1 score predictive of the functional prognosis of patients at discharge from a hospitalization motivated by a CI
Time frame: Up to 6 months
Comparison of observed correlations between ICDIM 1 and the change in mRS score before hospitalization and its value assessed at discharge adjusted for length of stay
Compare the performance of the artificial intelligence-based ICDIM 1 score with the performance of the NIHSS reference score
Time frame: Up to 6 months
Comparison of the observed correlations between the NHISS score and this same change in the mRS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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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. This study is not recruiting at the moment.
Virginie BOURSIER principal investigator
Fondation Hôpital Saint-Joseph
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 Cerebral Infarction, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginie BOURSIER (01 44 12 33 33 ext. + 33, vboursier@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To construct a multidimensional ICDIM 1 score predictive of the functional prognosis of patients at discharge from a hospitalization motivated by a CI (time frame: Up to 6 months). The study lists 2 primary outcomes in all. 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 7 Mar 2023.