Cardiovascular DiseasesOCEANUSNCT03065413
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)
An observational study of Cardiovascular Diseases and Risk Factor, Cardiovascular, run by Naval Hospital, Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Risk Factor, Cardiovascular
- How many people
- 3,000 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2014to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals
Who may be able to join
- -
Who cannot join
- Non signed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Athens Naval Hospital
Athens, Athens, 11527
Antonios Mastrokostopoulos, MD MSc, 00302107261000, amastrokostopoulos@yahoo.com
Georgios Katsimagklis, MD, 00302107261629, gvkats@yahoo.gr
About this study
Official title: The PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases (OCEANUS Study)
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
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence / prevalence of CVD
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startOct 2014
- Primary completionDec 2025 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Hospital, Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MASTROKOSTOPOULOS ANTONIOS, Naval Hospital, Athens
- Investigators
- Aikaterini Roumpi, MD MSc, Principal investigator, Athens Naval Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065413
- Sponsor's protocol ID
- F.700/28/165531/S.2743
- Acronym
- OCEANUS
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases (OCEANUS Study)
- ClinicalTrials.gov ID
- NCT03065413
- Acronym / sponsor ID
- OCEANUS / F.700/28/165531/S.2743
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Naval Hospital, AthensUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Non signed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence / prevalence of CVD
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aikaterini Roumpi, MD MSc principal investigator
Athens Naval Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Risk Factor, Cardiovascular, run by Naval Hospital, Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonios Mastrokostopoulos, MD MSc (00302107261000, amastrokostopoulos@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence / prevalence of CVD (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.