Psychosocial Risk Factors in Stroke and Myocardial Infarction

Not Applicable

Completed

• Conditions: Stroke; Myocardial Infarction
• Interventions: Biological: blood sample; Behavioral: questionnaires for psychosocial factors

• Registration Number: NCT02824107
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-08
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-06
• Primary Completion: 2019-08-26
• Study Completion: 2019-08-26
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with myocardial infarction	blood sample	-
patients with stroke	blood sample	-
patients with stroke	questionnaires for psychosocial factors	-
patients with myocardial infarction	questionnaires for psychosocial factors	-

Primary Outcome Measures

Name	Time	Method
number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease.	through the completion study an average of 6 month

Secondary Outcome Measures

Name	Time	Method
study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF	1st day

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Dijon, France