Psychosocial Risk Factors in Stroke and Myocardial Infarction (INEV@L)
Primary Purpose
Myocardial Infarction, Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
questionnaires for psychosocial factors
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patients with myocardial infarction
patients with stroke
Arm Description
Outcomes
Primary Outcome Measures
number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease.
Secondary Outcome Measures
study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF
Full Information
NCT ID
NCT02824107
First Posted
June 29, 2016
Last Updated
May 28, 2020
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02824107
Brief Title
Psychosocial Risk Factors in Stroke and Myocardial Infarction
Acronym
INEV@L
Official Title
INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 8, 2016 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with myocardial infarction
Arm Type
Experimental
Arm Title
patients with stroke
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Type
Behavioral
Intervention Name(s)
questionnaires for psychosocial factors
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF
Time Frame
1st day
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Psychosocial Risk Factors in Stroke and Myocardial Infarction
We'll reach out to this number within 24 hrs