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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.
 
ClinicalTrials.gov Identifier: NCT02824107
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE February 8, 2016
Actual Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF [ Time Frame: 1st day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychosocial Risk Factors in Stroke and Myocardial Infarction
Official Title  ICMJE INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Myocardial Infarction
  • Stroke
Intervention  ICMJE
  • Biological: blood sample
  • Behavioral: questionnaires for psychosocial factors
Study Arms  ICMJE
  • Experimental: patients with myocardial infarction
    Interventions:
    • Biological: blood sample
    • Behavioral: questionnaires for psychosocial factors
  • Experimental: patients with stroke
    Interventions:
    • Biological: blood sample
    • Behavioral: questionnaires for psychosocial factors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2020)
294
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2016)
100
Actual Study Completion Date  ICMJE August 26, 2019
Actual Primary Completion Date August 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824107
Other Study ID Numbers  ICMJE Béjot PARI 2015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP