OCEANUS: It is a Prospective Study Aiming to Identify Incidence and Prevalence of Cardiovascular Diseases, Changes in Physical Activity, Dietary Habits and Anxiety Depression Levels Through a Period of Time in the Naval Personnel (PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases)

Sponsor
Naval Hospital, Athens (Other)
Overall Status
Recruiting
CT.gov ID
NCT03065413
Collaborator
(none)
3,000
1
254
11.8

Study Details

Study Description

Brief Summary

Prospective study. Starting from 2014 all newly appointed 1st year cadets in Naval Academies will be enrolled until the class of 2025.

Physical examination, food frequency questionnaire, physical activity questionnaire, anxiety/depression questionnaire, medical history will be filled out at first interview.

Specific blood tests will be performed. Every participant will be interviewed every three years and will complete the same questionnaires.

Follow up period is determined ten years after last class enrollment

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    The PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases (OCEANUS Study)
    Actual Study Start Date :
    Oct 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2035

    Outcome Measures

    Primary Outcome Measures

    1. Incidence / prevalence of CVD [20 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Exclusion Criteria:
    • Non signed consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Athens Naval Hospital Athens Greece 11527

    Sponsors and Collaborators

    • Naval Hospital, Athens

    Investigators

    • Principal Investigator: Aikaterini Roumpi, MD MSc, Athens Naval Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MASTROKOSTOPOULOS ANTONIOS, Consultant Cardiologist, Naval Hospital, Athens
    ClinicalTrials.gov Identifier:
    NCT03065413
    Other Study ID Numbers:
    • F.700/28/165531/S.2743
    First Posted:
    Feb 27, 2017
    Last Update Posted:
    Feb 27, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 27, 2017