Myocardial InfarctionINEV@LNCT02824107
Psychosocial Risk Factors in Stroke and Myocardial Infarction
A study testing blood sample and questionnaires for psychosocial factors in people with Myocardial Infarction and Stroke, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on Psychosocial Factors. The aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health This study is… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Myocardial Infarction, Stroke
- What is being tested?
- blood sample and questionnaires for psychosocial factors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2016to 26 Aug 2019
- Phase
- Interventional
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have provided oral consent to participate
- Patients over 18 years
- Patients hospitalized for type 1 MI or ischemic stroke/TIA < 24H after symptom onset
- Age < 65 years
- With a professional activity (INSEE definition) at the time of the neuro or cardiovascular event
- At least one of the following risk factors: current smoking, obesity (waist circumference > 88 cm (W)/102 cm (M) or a waist/hip ratio 0.85(W)/0.9(M), sedentarity (physical activity < 150 min / week), alcohol consumption (> 3 standard glasses per day for men, > 2 standard glasses/d for women)
Who cannot join
- Adult under guardianship
- Patients without national health insurance cover
- Pregnant or breast-feeding women
- Clinical state making it impossible to use questionnaires or to measure risk factors
- Stroke or TIA not related to atheroma or cardioembolism (dissection, hemopathy…)
- type > 1 MI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
The aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on Psychosocial Factors.
The aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health This study is based on data from questionnaires (Quality of life at work, perceived stress, perceived disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking, obesity, sedentarity).
Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study because of blood sample
- Conditions
- Myocardial Infarction, Stroke
- Being tested
- blood sample, questionnaires for psychosocial factors
- Medical subject headings
- Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
questionnaires for psychosocial factorsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| patients with myocardial infarction | Experimental | Not described Receives: Biological: blood sample; Behavioral: questionnaires for psychosocial factors |
| patients with stroke | Experimental | Not described Receives: Biological: blood sample; Behavioral: questionnaires for psychosocial factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease.
Measured: through the completion study an average of 6 month
Secondary outcomes (1)
study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start8 Feb 2016
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 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
- NCT02824107
- Sponsor's protocol ID
- Béjot PARI 2015
- Acronym
- INEV@L
- Status last verified
- May 2020
- First submitted
- 29 Jun 2016
- Last updated
- 29 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
- ClinicalTrials.gov ID
- NCT02824107
- Acronym / sponsor ID
- INEV@L / Béjot PARI 2015
- Conditions
- Myocardial Infarction, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 6 Jul 2016 (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.
The aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on Psychosocial Factors.
The aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health This study is based on data from questionnaires (Quality of life at work, perceived stress, perceived disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking, obesity, sedentarity).
Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study because of blood sample
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with myocardial infarction | Experimental | Biological: blood sample, Behavioral: questionnaires for psychosocial factors |
| patients with stroke | Experimental | Biological: blood sample, Behavioral: questionnaires for psychosocial factors |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have provided oral consent to participate
- Patients over 18 years
- Patients hospitalized for type 1 MI or ischemic stroke/TIA < 24H after symptom onset
- Age < 65 years
- With a professional activity (INSEE definition) at the time of the neuro or cardiovascular event
Key exclusion criteria (6 listed)
- Adult under guardianship
- Patients without national health insurance cover
- Pregnant or breast-feeding women
- Clinical state making it impossible to use questionnaires or to measure risk factors
- Stroke or TIA not related to atheroma or cardioembolism (dissection, hemopathy…)
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 |
|---|---|---|
| blood sample | Biological | patients with myocardial infarction, patients with stroke |
| questionnaires for psychosocial factors | Behavioural | patients with myocardial infarction, patients with stroke |
Primary outcome
number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease.
Time frame: through the completion study an average of 6 month
1 secondary outcome
study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF
Time frame: 1st day
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 29 May 2020.
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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?
A study testing blood sample and questionnaires for psychosocial factors in people with Myocardial Infarction and Stroke, 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 6 inclusion and 6 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 29 May 2020. 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?
number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease. (time frame: through the completion study an average of 6 month). 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 29 May 2020.