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Completed

NCT Number: NCT02824107

Psychosocial Risk Factors in Stroke and Myocardial Infarction

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

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

questionnaires for psychosocial factors

Behavioral

Primary outcomes

  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 outcomes

  1. study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF

    Time frame: 1st day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention

Acronym: INEV@L

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2016
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.