It is a Prospective Study Aiming to Identify Incidence an... | NCT03065413

Studies
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)

NCT03065413

Sponsor

Naval Hospital, Athens

Status

Recruiting

Last Update Posted

Feb 27, 2017Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases
Risk Factor, Cardiovascular

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief Title

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)

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2035Estimated

First Submitted Date

Feb 22, 2017

First Submission Date that Met QC Criteria

Feb 22, 2017

First Posted Date

Feb 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2017

Last Update Posted Date

Feb 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

MASTROKOSTOPOULOS ANTONIOS, Consultant Cardiologist, Naval Hospital, AthensPrincipal Investigator

Lead Sponsor

Naval Hospital, AthensOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Measure	Description	Time Frame
Incidence / prevalence of CVD		20 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Non signed consent form

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy individuals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonios Mastrokostopoulos, MD MSc	Contact	00302107261000		amastrokostopoulos@yahoo.com
Georgios Katsimagklis, MD	Contact	00302107261629		gvkats@yahoo.gr

Overall Officials

Name	Affiliation	Role
Aikaterini Roumpi, MD MSc	Athens Naval Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Athens Naval Hospital	Recruiting	Athens	Athens	11527	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.