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Psychosocial Risk Factors in Stroke and Myocardial Infarction (INEV@L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02824107
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : May 29, 2020
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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

Condition or disease Intervention/treatment Phase
Myocardial Infarction Stroke Biological: blood sample Behavioral: questionnaires for psychosocial factors Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
Actual Study Start Date : February 8, 2016
Actual Primary Completion Date : August 26, 2019
Actual Study Completion Date : August 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: patients with myocardial infarction Biological: blood sample
Behavioral: questionnaires for psychosocial factors
Experimental: patients with stroke Biological: blood sample
Behavioral: questionnaires for psychosocial factors

Primary Outcome Measures :
  1. 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 Measures :
  1. study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF [ Time Frame: 1st day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02824107

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Centre Hospitalier Universitaire
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT02824107    
Other Study ID Numbers: Béjot PARI 2015
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Myocardial Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases