Psychosocial Risk Factors in Stroke and Myocardial Infarction

Stroke Clinical Trial

— INEV@L  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824107
• Other study ID #: Béjot PARI 2015
• Status: Completed
• Phase: N/A
• Start date: February 8, 2016
• Est. completion date: August 26, 2019

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Stroke

Intervention

Biological:
• blood sample

Behavioral:
• questionnaires for psychosocial factors

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of psychosocial factors (PSF) on the level of risk for neuro-cardiovascular disease.		through the completion study an average of 6 month
Secondary	study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF		1st day