Psychosocial Risk Factors in Stroke and Myocardial Infarction
INEV@L
INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
1 other identifier
interventional
294
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2016
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2019
CompletedMay 29, 2020
May 1, 2020
3.5 years
June 29, 2016
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease.
through the completion study an average of 6 month
Secondary Outcomes (1)
study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF
1st day
Study Arms (2)
patients with myocardial infarction
EXPERIMENTALpatients with stroke
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire
Dijon, 21079, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 6, 2016
Study Start
February 8, 2016
Primary Completion
August 26, 2019
Study Completion
August 26, 2019
Last Updated
May 29, 2020
Record last verified: 2020-05