Cerebrovascular AccidentsDiVaNCT04188457
Medical-economic Evaluation Comparing Intensive Outpatient Monitoring of Neuro-cardiovascular Diseases by Nurses, Doctors and Hospital and Private-sector Pharmacists, Compared to Usual Monitoring.
An observational study of Cerebrovascular Accidents and Myocardial Infarction, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cerebral Vascular Accidents (stroke) and Myocardial Infarction (MI), which share the same risk factors, treatments and pathophysiological mechanisms, have become two major public health problems due to the increase in their prevalence rate and the longer survival after such an event in developed countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accidents, Myocardial Infarction
- What is being tested?
- Usual follow-up and Intensive follow-up
- How many people
- 859 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2020to 9 Oct 2025
- 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: patients with stroke or myocardial infarction
Who may be able to join
- Patient or legal representative who has given oral consent
- Patient over 18 years of age
- Patient with:
- either a primary MI or a recurrent MI, not previously included, defined according to the criteria of the European Society of Cardiology and ICD-10
- either a primary stroke, a recurrent stroke not previously included, hemorrhagic, ischemic or Transient Ischemic Attack (TIA), defined according to WHO criteria, the TOAST score and the ICD-10, with a Rankin score < 5.
- Patient followed up in one of the 6 public health establishments of the GHT 21-52 (regional group of hospitals) or at the Valmy clinic in Dijon also participating in the project
- Patient with estimated survival beyond 12 months
Who cannot join
- A patient who is not affiliated to the national health insurance system;
- A patient subject to legal protection (curatorship, guardianship)
- To be a patient subject to a measure of judicial safeguard;
- Pregnant, parturient or breastfeeding woman;
- Admitted for a condition other than stroke, TIA and MI;
- Experiencing heart failure before the MI;
- Be managed in EHPAD before and/or after stroke or IDM.
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral Vascular Accidents (stroke) and Myocardial Infarction (MI), which share the same risk factors, treatments and pathophysiological mechanisms, have become two major public health problems due to the increase in their prevalence rate and the longer survival after such an event in developed countries.
International data, including French data and data from our own registries, illustrate that:
Read more
- risk factors that are common, mainly hypertension, smoking, high cholesterol or diabetes, remain insufficiently controlled, although they are easily detectable and treatable;
- the incidence rate of stroke has doubled in 20 years in people under 55 years of age, increasing the number of people with chronic disabilities;
- 1-month and 1-year mortality rates for stroke and MIs have decreased by 17% in 5 years, increasing the number of survivors but with chronic disabilities;
- the aging of the population and the arrival of the baby boomers of the 1950s in the at-risk age groups has increased the at-risk population;
- Stroke and MI recurrence rates reached a threshold of 6% / year, in contrast to the very high rates of re-hospitalization at 1 year: 30% post-stroke and 20% post-MI, due to poorly anticipated and controlled complications. These reasons explain the lack of significant progress in preventing recurrences, preventable complications (heart failure and arrhythmias after MI; falls, sphincter and swallowing disorders, dementia and arrhythmias after stroke) and re-admission. This observation is aggravated by problems of medical demography and therefore the availability of neurologists, cardiologists and general practitioners.
Local and foreign experiments have demonstrated the value of intensive, coordinated and multi-professional stroke and MI monitoring, including nurses, in terms of: better control of risk factors and reduction of the rate of re-hospitalization by recurrence in stroke follow-up; improvement of the patient's general condition, control of risk factors, reduction in the number of events, decrease in the number of re-hospitalizations and their duration in MI follow-up. The value of pharmacists' additional intervention in intensive post-MI follow-up compared to routine follow-up has also been demonstrated, particularly in terms of significant improvement in patient compliance.
The hypothesis is that 2 years of intensive follow-up for both post-stroke or post-MI patients, by trained hospital and liberal nurses, in conjunction with doctors and pharmacists, is of medico-economic interest compared to usual follow-up. Therefore a medico-economic evaluation was designed to evaluate the efficiency of this model, which combines community-based and recourse care, prevention and coordination of care compared to usual follow-up.
- Conditions
- Cerebrovascular Accidents, Myocardial Infarction
- Being tested
- Usual follow-up, Intensive follow-up
- Medical subject headings
- Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual follow-upOther
2 medical consultations (nurse and doctor) over 24 months
Intensive follow-upOther
10 medical visits (nurse, doctor, pharmacist) over 24 months
| Study group | Role | What they receive |
|---|---|---|
| Stroke - usual follow-up | Patient with either primary stroke, recurrent stroke, hemorrhagic, ischemic or Transient Ischemic Attack (TIA) with regular follow-up Receives: Other: Usual follow-up | |
| Stroke - intensive follow-up | Patient with either primary stroke, recurrent stroke, hemorrhagic, ischemic or Transient Ischemic Attack (TIA) with intensive follow-up Receives: Other: Intensive follow-up | |
| myocardial infarction - usual follow-up | Patient who has had a first or recurrent myocardial infarction with usual follow-up Receives: Other: Usual follow-up | |
| myocardial infarction -intensive follow-up | Patient who has had a first or recurrent myocardial infarction with intensive follow-up Receives: Other: Intensive follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility ratio of the intensive monitoring strategy for each condition (stroke / myocardial infarction)
24-month incremental cost-utility ratio associated with the intensive post-stroke or post-MI follow-up strategy compared to the usual post-stroke or post-MI follow-up strategy, expressed as cost per year of life gained in good health (costs / QALY, score measured using EQ-5D-5L®).
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start15 Oct 2020
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 859 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
- NCT04188457
- Sponsor's protocol ID
- BEJOT Article 51
- Acronym
- DiVa
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2019
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant anonymized individual participant data that underlie the results reported in the articles resulting from this clinical trial will be shared to researchers who provide a methodologically sound proposal, to achieve aims of the approved proposal, upon reasonnable request to the principal investigator (Prof. Yannick Béjot, yannick.bejot@chu-dijon.fr). The data will become available after 3 months following the publication of the article and for 5 years.
Publications
Bejot Y, Soilly AL, Bardou M, Duloquin G, Pommier T, Laurent G, Cottin Y, Vadot L, Adam H, Boulin M, Giroud M. Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study. BMJ Open. 2023 Apr 26;13(4):e070197. doi: 10.1136/bmjopen-2022-070197.
PubMed 37185649
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical-economic Evaluation Comparing Intensive Outpatient Monitoring of Neuro-cardiovascular Diseases by Nurses, Doctors and Hospital and Private-sector Pharmacists, Compared to Usual Monitoring.
- ClinicalTrials.gov ID
- NCT04188457
- Acronym / sponsor ID
- DiVa / BEJOT Article 51
- Conditions
- Cerebrovascular Accidents, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 859 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 6 Dec 2019 (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.
Cerebral Vascular Accidents (stroke) and Myocardial Infarction (MI), which share the same risk factors, treatments and pathophysiological mechanisms, have become two major public health problems due to the increase in their prevalence rate and the longer survival after such an event in developed countries.
International data, including French data and data from our own registries, illustrate that:
- risk factors that are common, mainly hypertension, smoking, high cholesterol or diabetes, remain insufficiently controlled, although they are easily detectable and treatable;
- the incidence rate of stroke has doubled in 20 years in people under 55 years of age, increasing the number of people with chronic disabilities;
- 1-month and 1-year mortality rates for stroke and MIs have decreased by 17% in 5 years, increasing the number of survivors but with chronic disabilities;
- the aging of the population and the arrival of the baby boomers of the 1950s in the at-risk age groups has increased the at-risk population;
- Stroke and MI recurrence rates reached a threshold of 6% / year, in contrast to the very high rates of re-hospitalization at 1 year: 30% post-stroke and 20% post-MI, due to poorly anticipated and controlled complications. These reasons explain the lack of significant progress in preventing recurrences, preventable complications (heart failure and arrhythmias after MI; falls, sphincter and swallowing disorders, dementia and arrhythmias after stroke) and re-admission. This observation is aggravated by problems of medical demography and therefore the availability of neurologists, cardiologists and general practitioners.
Local and foreign experiments have demonstrated the value of intensive, coordinated and multi-professional stroke and MI monitoring, including nurses, in terms of: better control of risk factors and reduction of the rate of re-hospitalization by recurrence in stroke follow-up; improvement of the patient's general condition, control of risk factors, reduction in the number of events, decrease in the number of re-hospitalizations and their duration in MI follow-up. The value of pharmacists' additional intervention in intensive post-MI follow-up compared to routine follow-up has also been demonstrated, particularly in terms of significant improvement in patient compliance.
The hypothesis is that 2 years of intensive follow-up for both post-stroke or post-MI patients, by trained hospital and liberal nurses, in conjunction with doctors and pharmacists, is of medico-economic interest compared to usual follow-up. Therefore a medico-economic evaluation was designed to evaluate the efficiency of this model, which combines community-based and recourse care, prevention and coordination of care compared to usual follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stroke - usual follow-up | – | Other: Usual follow-upPatient with either primary stroke, recurrent stroke, hemorrhagic, ischemic or Transient Ischemic Attack (TIA) with regular follow-up |
| Stroke - intensive follow-up | – | Other: Intensive follow-upPatient with either primary stroke, recurrent stroke, hemorrhagic, ischemic or Transient Ischemic Attack (TIA) with intensive follow-up |
| myocardial infarction - usual follow-up | – | Other: Usual follow-upPatient who has had a first or recurrent myocardial infarction with usual follow-up |
| myocardial infarction -intensive follow-up | – | Other: Intensive follow-upPatient who has had a first or recurrent myocardial infarction with intensive follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with stroke or myocardial infarction
Key inclusion criteria (7 listed)
- Patient or legal representative who has given oral consent
- Patient over 18 years of age
- Patient with:
- Patient followed up in one of the 6 public health establishments of the GHT 21-52 (regional group of hospitals) or at the Valmy clinic in Dijon also participating in the project
- Patient with estimated survival beyond 12 months
Key exclusion criteria (7 listed)
- A patient who is not affiliated to the national health insurance system;
- A patient subject to legal protection (curatorship, guardianship)
- To be a patient subject to a measure of judicial safeguard;
- Pregnant, parturient or breastfeeding woman;
- Admitted for a condition other than stroke, TIA and MI;
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 |
|---|---|---|
| Usual follow-up2 medical consultations (nurse and doctor) over 24 months | Other | Stroke - usual follow-up, myocardial infarction - usual follow-up |
| Intensive follow-up10 medical visits (nurse, doctor, pharmacist) over 24 months | Other | Stroke - intensive follow-up, myocardial infarction -intensive follow-up |
Primary outcome
Cost-utility ratio of the intensive monitoring strategy for each condition (stroke / myocardial infarction)
Time frame: 24 month
24-month incremental cost-utility ratio associated with the intensive post-stroke or post-MI follow-up strategy compared to the usual post-stroke or post-MI follow-up strategy, expressed as cost per year of life gained in good health (costs / QALY, score measured using EQ-5D-5L®).
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 30 Dec 2025.
- Derived from this study: PubMed 37185649Bejot Y, Soilly AL, Bardou M, Duloquin G, Pommier T, Laurent G, Cottin Y, Vadot L, Adam H, Boulin M, Giroud M. Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study. BMJ Open. 2023 Apr 26;13(4):e070197. doi: 10.1136/bmjopen-2022-070197.
- Individual participant dataSharing planned: Yes. Relevant anonymized individual participant data that underlie the results reported in the articles resulting from this clinical trial will be shared to researchers who provide a methodologically sound proposal, to achieve aims of the approved proposal, upon reasonnable request to the principal investigator (Prof. Yannick Béjot, yannick.bejot@chu-dijon.fr). The data will become available after 3 months following the publication of the article and for 5 years.
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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.
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 Cerebrovascular Accidents and Myocardial Infarction, 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 7 inclusion and 7 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 30 Dec 2025. 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?
Cost-utility ratio of the intensive monitoring strategy for each condition (stroke / myocardial infarction) (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188457, which also lists 1 linked publication.
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 30 Dec 2025.