Cerebrovascular AccidentAVCBCTNCT04925869
Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)
An observational study of Cerebrovascular Accident and Thrombolysis, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
The objective of this study is to specify the typology of CVA in French Guiana by prospectively comparing consecutive strokes observed at each of the three study sites (Cayenne, Tours, Besançon) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Thrombolysis
- What is being tested?
- Observational study
- How many people
- 300 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 7 May 2019to 31 Mar 2020
- 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 patients with MRI-confirmed CVA admitted to the hospitals of Besançon, Cayenne, and Tours.
Who may be able to join
- Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI
Who cannot join
- Age under 18 years
- Absence of MRI
Trial locations and contacts
1 site in 1 country.
French Guiana1 site
Centre Hospitalier de Cayenne
Cayenne, Guyane, 97306
About this study
The objective of this study is to specify the typology of CVA in French Guiana by prospectively comparing consecutive strokes observed at each of the three study sites (Cayenne, Tours, Besançon)
Read the detailed description
CVA is a public health problem that is managed in a codified manner by the Neurovascular Units (NU). In Cayenne, in the absence of a NU, strokes are managed directly in the emergency room by 24-hour telemedicine provided by the neurovascular team at the Besançon University Hospital. The vascular neurologist can perform a clinical examination remotely in a dedicated examination room and has access to magnetic resonance imaging by image transfer. The Tours and Besançon university hospitals each have a regional reference NU. The coordinating investigator of the study is the head of the neurology department of the Tours University Hospital, currently on an extended mission in Cayenne. The initial emergency management of a person with stroke who is hospitalized is comparable between the three regions studied.
Epidemiological studies show disparities in stroke mortality and vascular risk factors between French regions. The stroke mortality rate in French Guiana in 2013 (72 per 100 000 population per year) was twice that of metropolitan France. The standardized prevalence rate of diabetes in French Guiana is 7.1% of the population compared with 4.4% in metropolitan France, and the prevalence of hypertension is twice as high among women in the French Guiana West Indies compared with metropolitan France. There are twice as many obese persons (BMI>30) in Guyanese women compared with metropolitan France.
We propose a prospective observational study based on the following hypothesis:
The average age of stroke occurrence, its type (ischemic or hemorrhagic), the vascular territories involved, the vascular risk factors, and the pre-hospital and intra-hospital management times will be superimposable between two metropolitan regions but different in French Guyana.
- Conditions
- Cerebrovascular Accident, Thrombolysis
- Being tested
- Observational study
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| The hospitals of Besançon | Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon Receives: Other: Observational study | |
| the hospitals of Cayenne | Adult patients with MRI-confirmed CVA admitted to the hospitals of Cayenne. Receives: Other: Observational study | |
| the hospitals of Tours | Adult patients with MRI-confirmed CVA admitted to the hospitals of Tours. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence
Clinical assessment of stroke (NIHSS score) and systematic collection of vascular risk factors (diabetes, hypertension, dyslipidemia, emboligic heart disease) Suspected mechanism (TOAST). Modified Rankin score
Measured: 3 months
Secondary outcomes (1)
Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis
Time to access care and management. The following will be specified: the time between the onset of symptoms and admission, MRI, and thrombolysis, if applicable.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start7 May 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional Universitaire de Tours, Centre Hospitalier Régional Universitaire, Besançon
- Responsible party
- Sponsor
- Investigators
- Bertrand De Toffol, PHD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925869
- Sponsor's protocol ID
- AVC BCT
- Acronym
- AVCBCT
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 14 Jun 2021
- 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 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Cerebrovascular Accidents (CVA) in 3 French Cities (Besançon, Cayenne and Tours)
- ClinicalTrials.gov ID
- NCT04925869
- Acronym / sponsor ID
- AVCBCT / AVC BCT
- Conditions
- Cerebrovascular Accident, Thrombolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional Universitaire de Tours, Centre Hospitalier Régional Universitaire, Besançon
- Study start
- 7 May 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 14 Jun 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.
The objective of this study is to specify the typology of CVA in French Guiana by prospectively comparing consecutive strokes observed at each of the three study sites (Cayenne, Tours, Besançon)
Detailed description
CVA is a public health problem that is managed in a codified manner by the Neurovascular Units (NU). In Cayenne, in the absence of a NU, strokes are managed directly in the emergency room by 24-hour telemedicine provided by the neurovascular team at the Besançon University Hospital. The vascular neurologist can perform a clinical examination remotely in a dedicated examination room and has access to magnetic resonance imaging by image transfer. The Tours and Besançon university hospitals each have a regional reference NU. The coordinating investigator of the study is the head of the neurology department of the Tours University Hospital, currently on an extended mission in Cayenne. The initial emergency management of a person with stroke who is hospitalized is comparable between the three regions studied.
Epidemiological studies show disparities in stroke mortality and vascular risk factors between French regions. The stroke mortality rate in French Guiana in 2013 (72 per 100 000 population per year) was twice that of metropolitan France. The standardized prevalence rate of diabetes in French Guiana is 7.1% of the population compared with 4.4% in metropolitan France, and the prevalence of hypertension is twice as high among women in the French Guiana West Indies compared with metropolitan France. There are twice as many obese persons (BMI>30) in Guyanese women compared with metropolitan France.
We propose a prospective observational study based on the following hypothesis:
The average age of stroke occurrence, its type (ischemic or hemorrhagic), the vascular territories involved, the vascular risk factors, and the pre-hospital and intra-hospital management times will be superimposable between two metropolitan regions but different in French Guyana.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The hospitals of Besançon | – | Other: Observational studyAdult patients with MRI-confirmed CVA admitted to the hospitals of Besançon |
| the hospitals of Cayenne | – | Other: Observational studyAdult patients with MRI-confirmed CVA admitted to the hospitals of Cayenne. |
| the hospitals of Tours | – | Other: Observational studyAdult patients with MRI-confirmed CVA admitted to the hospitals of Tours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with MRI-confirmed CVA admitted to the hospitals of Besançon, Cayenne, and Tours.
Key inclusion criteria (1 listed)
- Patient with a diagnosis of Cerebral Vascular Accident confirmed on MRI
Key exclusion criteria (2 listed)
- Age under 18 years
- Absence of MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyObservational study | Other | The hospitals of Besançon, the hospitals of Cayenne, the hospitals of Tours |
Primary outcome
Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence
Time frame: 3 months
Clinical assessment of stroke (NIHSS score) and systematic collection of vascular risk factors (diabetes, hypertension, dyslipidemia, emboligic heart disease) Suspected mechanism (TOAST). Modified Rankin score
1 secondary outcome
Compare the time required for treatment between Cayenne, Besançon and Tours in the event of an indication for thrombolysis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- 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. This study is not recruiting at the moment.
Bertrand De Toffol, PHD principal investigator
Centre Hospitalier de Cayenne
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 and Thrombolysis, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 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: finished, as of the sponsor's last update on 14 Jun 2021. 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 French Guiana. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the types of CVA and assess their risk factors on clinical, radiological and biological evidence (time frame: 3 months). 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 14 Jun 2021.