Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02824107
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Myocardial Infarction Stroke Biological: blood sample Behavioral: questionnaires for psychosocial factors Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention
Actual Study Start Date : February 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: patients with myocardial infarction Biological: blood sample
Behavioral: questionnaires for psychosocial factors
Experimental: patients with stroke Biological: blood sample
Behavioral: questionnaires for psychosocial factors



Primary Outcome Measures :
  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 Outcome Measures :
  1. study the proportion of diméthyl-arginine asymetrical (ADMA) in patients with PSF [ Time Frame: 1st day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824107


Contacts
Layout table for location contacts
Contact: Yannick BEJOT 3 80.29.37.53 ext +33 yannick.bejot@chu-dijon.fr

Locations
Layout table for location information
France
Centre Hospitalier Universitaire Recruiting
Dijon, France, 21079
Contact: Yannick BEJOT    3 80.29.37.53 ext +33    yannick.bejot@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02824107     History of Changes
Other Study ID Numbers: Béjot PARI 2015
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Infarction
Myocardial Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases