Symptomatic CVA (de Novo CVA)INDIANCT01906463
Social and Prognostic Inequalities in Patients Hospitalised for Cerebrovascular Accident (CVA) in Four Contrasting French Departments
An observational study of Symptomatic CVA (de Novo CVA), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This study should also raise questions about the interest and feasibility of establishing a permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected doubling of the population of persons aged over 60 years and the foreseeable changes in lifestyle will increase the burden of this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic CVA (de Novo CVA)
- How many people
- 1,612 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Oct 2015
- 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: Patient from CHU Dijon , CHU Point-à-Pitre and CHU Fort-de-France,CHU Guyane
Who may be able to join
- Pre- inclusion
- Patients who have received information about the study (directly or via a person of trust),
- Patients aged more than 18 years,
- Patient hospitalised for a suspected first symptomatic CVA (whatever the mechanism), preceded or not by a transient ischemic attack (TIA),
- Patients with a cerebral imaging examination (CT-scan and/or MRI),
- in Guyana, suspicion of a first CVA according to WHO clinical criteria and who died before the authorised images for descriptive purposes,
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- Patients able to answer questions personally or through a parent or a person of trust.
- Definitive inclusion
- Patients with confirmed CVA diagnosed according to clinical criteria (WHO criteria) and imaging criteria.
Who cannot join
- - Patients who refuse to take part in the study,
- Patients with prior symptomatic CVA,
- Patients without cerebral imaging (except in Guyana, for patients with suspected CVA who died before imaging),
- Patients with another severe evolutive disease that could cause death in the weeks following the CVA,
- Patients who cannot be contacted by telephone at 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social and Prognostic Inequalities in Patients Hospitalised for Cerebrovascular Accident (CVA) in Four Contrasting French Departments: Côte d'Or, Martinique, Guadeloupe and French Guyana Analysis of Their Impact on Vascular Risk Factors and the Management of CVA
This study should also raise questions about the interest and feasibility of establishing a permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected doubling of the population of persons aged over 60 years and the foreseeable changes in lifestyle will increase the burden of this disease, in particular since the region is marked by a high prevalence of arterial hypertension and diabetes and a high level of precarity. In addition, this study will provide epidemiological information on CVA, its risk factors and management, which are non-existent for the department of French Guyana where the health environment is manifestly insufficient. These data should make it possible to better evaluate the resources available and the healthcare needs in Guyana.
- Conditions
- Symptomatic CVA (de Novo CVA)
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical history
Measured: Baseline
Secondary outcomes (3)
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Measured: Month 6
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Measured: Month 1
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic CVA (de Novo CVA)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906463
- Sponsor's protocol ID
- bonithon PHRC N 2010
- Acronym
- INDIA
- Status last verified
- Dec 2018
- First submitted
- 12 Jul 2013
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Prognostic Inequalities in Patients Hospitalised for Cerebrovascular Accident (CVA) in Four Contrasting French Departments: Côte d'Or, Martinique, Guadeloupe and French Guyana Analysis of Their Impact on Vascular Risk Factors and the Management of CVA
- ClinicalTrials.gov ID
- NCT01906463
- Acronym / sponsor ID
- INDIA / bonithon PHRC N 2010
- Conditions
- Symptomatic CVA (de Novo CVA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,612 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Jul 2013 (estimated)
- 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.
This study should also raise questions about the interest and feasibility of establishing a permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected doubling of the population of persons aged over 60 years and the foreseeable changes in lifestyle will increase the burden of this disease, in particular since the region is marked by a high prevalence of arterial hypertension and diabetes and a high level of precarity. In addition, this study will provide epidemiological information on CVA, its risk factors and management, which are non-existent for the department of French Guyana where the health environment is manifestly insufficient. These data should make it possible to better evaluate the resources available and the healthcare needs in Guyana.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient from CHU Dijon , CHU Point-à-Pitre and CHU Fort-de-France,CHU Guyane
Key inclusion criteria (9 listed)
- Pre- inclusion
- Patients who have received information about the study (directly or via a person of trust),
- Patients aged more than 18 years,
- Patient hospitalised for a suspected first symptomatic CVA (whatever the mechanism), preceded or not by a transient ischemic attack (TIA),
- Patients with a cerebral imaging examination (CT-scan and/or MRI),
Key exclusion criteria (5 listed)
- - Patients who refuse to take part in the study,
- Patients with prior symptomatic CVA,
- Patients without cerebral imaging (except in Guyana, for patients with suspected CVA who died before imaging),
- Patients with another severe evolutive disease that could cause death in the weeks following the CVA,
- Patients who cannot be contacted by telephone at 1 month.
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
Medical history
Time frame: Baseline
3 secondary outcomes
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Time frame: Month 6
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Time frame: Month 1
Follow-up questionnaire: functional handicap, intercurrent hospitalisation, vital status
Time frame: Month 12
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 27 Dec 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Symptomatic CVA (de Novo CVA), run by Centre Hospitalier Universitaire Dijon 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 9 inclusion and 5 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 27 Dec 2018. 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?
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?
Medical history (time frame: Baseline). 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 27 Dec 2018.