Psychosocial Risk Factors in Stroke and Myocardial Infarction

NCT ID: NCT02824107

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-08

Study Completion Date

2019-08-26

Brief Summary

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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

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Conditions

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Myocardial Infarction Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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patients with myocardial infarction

Group Type EXPERIMENTAL

blood sample

Intervention Type BIOLOGICAL

questionnaires for psychosocial factors

Intervention Type BEHAVIORAL

patients with stroke

Group Type EXPERIMENTAL

blood sample

Intervention Type BIOLOGICAL

questionnaires for psychosocial factors

Intervention Type BEHAVIORAL

Interventions

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blood sample

Intervention Type BIOLOGICAL

questionnaires for psychosocial factors

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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Béjot PARI 2015

Identifier Type: -

Identifier Source: org_study_id

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