Transient Ischemic AttackMEDECO-AITNCT03605355
Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes
An observational study of Transient Ischemic Attack, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2019to Dec 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: Stroke patients, to adapt to the recent change in the typology of new ischemic stroke in Western Europe, which for the most part are transient (30%) or minor ischemic strokes (35%). %). The profile of these patients is indeed compatible with outpatient care which should lead to the adaptation of the offer of care.
Who may be able to join
- Hospitalization in the TIA clinic in Toulouse Hospital (a day clinic)
- Having presented within the previous 7 days a transient ischemic attack or a minor stroke
- Affiliated to a social protection system
- To have given no opposition to participation in the study
Who cannot join
- Patients with a transient ischemic attack - mimic (such as migraine or seizure)
- Patients under protection of justice
- Pregnant and / or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse
Toulouse, 31059
Hélène Derumeaux-Burel, MD, 05 61 77 87 75 ext. 33, derumeaux.h@chu-toulouse.fr
Isabelle Olivier, PhD, 05 61 77 70 51, olivier.i@chu-toulouse.fr
About this study
Official title: Feasibility Study on the Medical and Economic Consequences of an Ambulatory Transient Ischemic Attack and Minor Stroke Management
The effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on their economic interest and none in France.
Patient's typology (younger patient, no sequel, no disability) with Transient ischemic attack (TIA) and minor stroke (MS) makes them compatible with ambulatory management.
Read the detailed description
Only two hospitals in France can take care patients with TIA or MS in an outpatient setting :Bichat hospital in Paris and Toulouse University Hospital. The effectiveness of this management has been demonstrated since recurrence stroke risk is reduced by 80% at one year. An English study (EXPRESS study) [2] showed a gain of 624 pounds with an ambulatory management compared to a conventional one. No studies are available in France on this subject.
The aim of this study is to test the feasibility of a collection of medical and economic data on a prospective way. The investigators collect medical (Cerebrovascular events, Stroke) and economic (direct and indirect costs) data concerning patients who were managed in TIA clinic in Toulouse Hospital. The medical data will be compiled with available French and International literature. The economic data will be compiled with available data in PMSI and health insurance database. This study aims to prepare a multicenter cohort to compare the cost effectiveness ratio between ambulatory and conventional management.
- Conditions
- Transient Ischemic Attack
- Keywords
- minor stroke, cost-effectiveness, feasibility, day clinic
- Medical subject headings
- Ischemic Attack, Transient
What is being measured
The primary outcome is the main question the study is designed to answer.
The average cost-effectiveness ratio at 3 month
The average cost-effectiveness ratio at 3 month where the effectiveness is the 3-month cerebro vascular event rate and the costs taken into account are medical and non-medical direct costs and indirect costs limited to work stoppages.
Measured: 3 months
Secondary outcomes (8)
Percentage of full cost collection
Percentage of patients for whom total direct medical, direct non-medical, and indirect costs could be collected by comparing with health insurance data
Measured: 1 year
Concordance between monitoring data collected in different database
Concordance between prospectively collected monitoring data, supplemented by data from the PMSI database of Toulouse University Hospital and data extracted from the health insurance database via NIR.
Measured: 1 year
Recurrence rate of cerebro and cardiovascular events at 7 days
Recurrence rate of cerebro and cardiovascular events at 7 days : Stroke, myocardial infarction, vascular death within 30 days of stroke or MI
Measured: 7 days
Recurrence rate of cerebro and cardiovascular events at 3 months
Recurrence rate of cerebro and cardiovascular events at 3 months : Stroke, myocardial infarction, vascular death within 30 days of stroke or MI
Measured: 3 months
Recurrence rate of cerebro and cardiovascular events at one year
Recurrence rate of cerebro and cardiovascular events at one year : Stroke, myocardial infarction, vascular death within 30 days of stroke or MI
Measured: one year
Average cost-effectiveness ratio at one year
The average cost - effectiveness ratio with the criterion of effectiveness the recurrence rate for cardiovascular events at one year (stroke, myocardial infarction, vascular death occurring within 30 days after a stroke or an IDM), and as cost criteria, direct medical and non-medical costs and indirect costs limited to work stoppages
Measured: one year
Percentage of patients treated in TIA clinic who had first medical contact with a senior
Percentage of patients attending the AIT Clinic who had first medical contact with a senior neurology
Measured: 1 day
Percentage of patients with statin prescription at discharge
Percentage of patients with statin prescription at discharge
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start7 Sep 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Derumeaux-Burel, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605355
- Sponsor's protocol ID
- RC31/17/0349
- Other IDs
- 2018-A01444-51
- Acronym
- MEDECO-AIT
- Status last verified
- Jan 2019
- First submitted
- 19 Jul 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Medical and Economic Consequences of an Ambulatory Transient Ischemic Attack and Minor Stroke Management
- ClinicalTrials.gov ID
- NCT03605355
- Acronym / sponsor ID
- MEDECO-AIT / RC31/17/0349
- Conditions
- Transient Ischemic Attack
- Keywords
- minor stroke, cost-effectiveness, feasibility, day clinic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 Sep 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jul 2018 (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 effectiveness of outpatient management of minor TIAs and strokes in the context of a dedicated outpatient pathway with specialized care has been demonstrated and has resulted in an 80% decrease in stroke in the year followed the AIT (EXPRESS and SOS-TIA studies) At the same time, few studies have been conducted on their economic interest and none in France.
Patient's typology (younger patient, no sequel, no disability) with Transient ischemic attack (TIA) and minor stroke (MS) makes them compatible with ambulatory management.
Detailed description
Only two hospitals in France can take care patients with TIA or MS in an outpatient setting :Bichat hospital in Paris and Toulouse University Hospital. The effectiveness of this management has been demonstrated since recurrence stroke risk is reduced by 80% at one year. An English study (EXPRESS study) [2] showed a gain of 624 pounds with an ambulatory management compared to a conventional one. No studies are available in France on this subject.
The aim of this study is to test the feasibility of a collection of medical and economic data on a prospective way. The investigators collect medical (Cerebrovascular events, Stroke) and economic (direct and indirect costs) data concerning patients who were managed in TIA clinic in Toulouse Hospital. The medical data will be compiled with available French and International literature. The economic data will be compiled with available data in PMSI and health insurance database. This study aims to prepare a multicenter cohort to compare the cost effectiveness ratio between ambulatory and conventional management.
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
- Stroke patients, to adapt to the recent change in the typology of new ischemic stroke in Western Europe, which for the most part are transient (30%) or minor ischemic strokes (35%). %). The profile of these patients is indeed compatible with outpatient care which should lead to the adaptation of the offer of care.
Key inclusion criteria (4 listed)
- Hospitalization in the TIA clinic in Toulouse Hospital (a day clinic)
- Having presented within the previous 7 days a transient ischemic attack or a minor stroke
- Affiliated to a social protection system
- To have given no opposition to participation in the study
Key exclusion criteria (3 listed)
- Patients with a transient ischemic attack - mimic (such as migraine or seizure)
- Patients under protection of justice
- Pregnant and / or breastfeeding woman
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
The average cost-effectiveness ratio at 3 month
Time frame: 3 months
The average cost-effectiveness ratio at 3 month where the effectiveness is the 3-month cerebro vascular event rate and the costs taken into account are medical and non-medical direct costs and indirect costs limited to work stoppages.
8 secondary outcomes
Percentage of full cost collection
Time frame: 1 year
Concordance between monitoring data collected in different database
Time frame: 1 year
Recurrence rate of cerebro and cardiovascular events at 7 days
Time frame: 7 days
Recurrence rate of cerebro and cardiovascular events at 3 months
Time frame: 3 months
Recurrence rate of cerebro and cardiovascular events at one year
Time frame: one year
Average cost-effectiveness ratio at one year
Time frame: one year
Percentage of patients treated in TIA clinic who had first medical contact with a senior
Time frame: 1 day
Percentage of patients with statin prescription at discharge
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Hélène Derumeaux-Burel, MD principal investigator
University Hospital, Toulouse
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 Transient Ischemic Attack, run by University Hospital, Toulouse 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 3 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 31 Jan 2019. 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 Hélène Derumeaux-Burel, MD (05 61 77 87 75, derumeaux.h@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average cost-effectiveness ratio at 3 month (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 31 Jan 2019.