Cerebrovascular Accident (CVA)StrokecopilotNCT05534295
Strokecopilot: A Precision Medicine Tool in the Stroke Emergency
An observational study of Cerebrovascular Accident (CVA), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Ischemic stroke or cerebral infarction (CI) is an immediate emergency affecting approximately 100,000 - 150,000 patients each year in France and is managed in the neurovascular intensive care unit (NICU). Recanalization treatments can prevent disability, but patients must be carefully selected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident (CVA)
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2022to 31 Dec 2023
- 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: Adult patient (>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg
Who may be able to join
- Adult patient (>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg from January 01, 2017 to December 31, 2021
Who cannot join
- Subjects who have expressed their opposition to the use of their data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service : Unité Neurovasculaire - CHU de Strasbourg - France
Strasbourg, 67091
Valérie WOLFF, MD, PhD, 33 3 88 12 85 19, valerie.wolff@chru-strasbourg.fr
Valérie WOLFF, MD, PhD
About this study
Ischemic stroke or cerebral infarction (CI) is an immediate emergency affecting approximately 100,000 - 150,000 patients each year in France and is managed in the neurovascular intensive care unit (NICU). Recanalization treatments can prevent disability, but patients must be carefully selected. Knowledge in this field is evolving rapidly, which tends to make management more complex and personalized. In addition, the permanence of thrombolysis channels involves neurologists of all expertise. Decision support tools are desirable to enable precision medicine in stroke. Strokecopilot is a web application developed by the principal investigator. Its algorithm contextualizes the patient in a set of evidence-based medicine references (recommendations and clinical trials) and gives the result of their cross-referencing to the user to indicate theoretical indications for intravenous thrombolysis and mechanical thrombectomy.
- Conditions
- Cerebrovascular Accident (CVA)
- Keywords
- cerebrovascular accident (CVA), Ischemic stroke, thrombolysis channels, intravenous thrombolysis, mechanical thrombectomy
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of thrombolysis data for the development of an algorithm to detect thrombolysis
Measured: Files analysed retrospectively from January 01, 2017 to December 31, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start10 May 2022
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular Accident (CVA)Studies 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie WOLFF, MD, PhD, Principal investigator, Service : Unité Neurovasculaire - CHU de Strasbourg - FranceStanislas DEMUTH, MD, Principal investigator, Service : Unité Neurovasculaire - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534295
- Sponsor's protocol ID
- 8589
- Acronym
- Strokecopilot
- Status last verified
- Dec 2023
- First submitted
- 2 Sep 2022
- Last updated
- 13 Dec 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strokecopilot: A Precision Medicine Tool in the Stroke Emergency
- ClinicalTrials.gov ID
- NCT05534295
- Acronym / sponsor ID
- Strokecopilot / 8589
- Conditions
- Cerebrovascular Accident (CVA)
- Keywords
- cerebrovascular accident (CVA), Ischemic stroke, thrombolysis channels, intravenous thrombolysis, mechanical thrombectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Sep 2022 (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.
Ischemic stroke or cerebral infarction (CI) is an immediate emergency affecting approximately 100,000 - 150,000 patients each year in France and is managed in the neurovascular intensive care unit (NICU). Recanalization treatments can prevent disability, but patients must be carefully selected. Knowledge in this field is evolving rapidly, which tends to make management more complex and personalized. In addition, the permanence of thrombolysis channels involves neurologists of all expertise. Decision support tools are desirable to enable precision medicine in stroke. Strokecopilot is a web application developed by the principal investigator. Its algorithm contextualizes the patient in a set of evidence-based medicine references (recommendations and clinical trials) and gives the result of their cross-referencing to the user to indicate theoretical indications for intravenous thrombolysis and mechanical thrombectomy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg
Key inclusion criteria (1 listed)
- Adult patient (>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg from January 01, 2017 to December 31, 2021
Key exclusion criteria (1 listed)
- Subjects who have expressed their opposition to the use of their data for scientific research purposes.
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
Retrospective analysis of thrombolysis data for the development of an algorithm to detect thrombolysis
Time frame: Files analysed retrospectively from January 01, 2017 to December 31, 2021 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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.
Valérie WOLFF, MD, PhD principal investigator
Service : Unité Neurovasculaire - CHU de Strasbourg - France
Stanislas DEMUTH, MD principal investigator
Service : Unité Neurovasculaire - CHU de Strasbourg - France
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 Accident (CVA), run by University Hospital, Strasbourg, France 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 1 inclusion and 1 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 13 Dec 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 Valérie WOLFF, MD, PhD (33 3 88 12 85 19, valerie.wolff@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of thrombolysis data for the development of an algorithm to detect thrombolysis (time frame: Files analysed retrospectively from January 01, 2017 to December 31, 2021 will be examined). 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 13 Dec 2023.