Beta-Thalassemia TraitNCT02428023
B-Thalasaemia Trait and Its Possible Cardioprotective Role
An observational study of Beta-Thalassemia Trait and Coronary Artery Disease, run by 404 General Military Hospital, Larissa at 1 site in Greece.
Trial summary
Our purpose is to investigate whether thallasaemia trait offers protection against cardiovascular events and whether this can be applied to specific characteristics of these people ( better lipid profile , better blood pressure profile) as scientific literature suggests. Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Beta-Thalassemia Trait, Coronary Artery Disease
- How many people
- 2,500 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2015to Apr 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 2500 subjects who serve in military units in Thessaly Greece
Who may be able to join
- voluntary participation,
- Subjects with Thalassemia treat will be confirmed of their treat by electrophoresis -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
404 Military Hospital
Larissa
ELIAS ANDREANIDES, PhD, +3 6944570406, elandreanides@gmail.com
Maria Malliarou, PhD, mmalliarou@gmail.com
About this study
Our purpose is to investigate whether thallasaemia trait offers protection against cardiovascular events and whether this can be applied to specific characteristics of these people ( better lipid profile , better blood pressure profile) as scientific literature suggests.
Read the detailed description
Thallasaemia is a major problem , especially in countries around the Mediterranean sea.On the other hand ,thallasaemia trait has been shown ,in a small number of studies , to have a possible protective role against CAD and stroke.These kind of studies have been contacted in Greece also ,and usually they enroll a small number of participants. In the study, investigators will enroll 2500 subjects who serve in military units in Thesally Greece. Firstly investigators will estimate the prevalence of thallasaemia trait in this population , as it is very high in this region and at the same time investigators will retrospectively record data from their personal files (which are annually recorded).
- Conditions
- Beta-Thalassemia Trait, Coronary Artery Disease
- Keywords
- Thalassemia, trait, coronary, stroke
- Medical subject headings
- Coronary Artery Disease, Thalassemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GrThalasaemia | estimation of IMT of the carotides arteries and calcium scoring | |
| GrNormal | estimation of IMT of the carotides arteries and calcium scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardioprotective role of Thalassemia Treat
Cardioprotective role of Thalassemia Treat
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-Thalassemia TraitStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- 404 General Military Hospital, Larissa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANDREANIDIS ELIAS, 404 General Military Hospital, Larissa
- Investigators
- Elias Andreanidis, PhD, Principal investigator, 404 General Military Hospital, Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428023
- Sponsor's protocol ID
- 404 General Military Hospital
- Status last verified
- Jan 2016
- First submitted
- 23 Apr 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-Thalasaemia Trait and Its Possible Cardioprotective Role
- ClinicalTrials.gov ID
- NCT02428023
- Acronym / sponsor ID
- 404 General Military Hospital
- Conditions
- Beta-Thalassemia Trait, Coronary Artery Disease
- Keywords
- Thalassemia, trait, coronary, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- 404 General Military Hospital, LarissaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- 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.
Our purpose is to investigate whether thallasaemia trait offers protection against cardiovascular events and whether this can be applied to specific characteristics of these people ( better lipid profile , better blood pressure profile) as scientific literature suggests.
Detailed description
Thallasaemia is a major problem , especially in countries around the Mediterranean sea.On the other hand ,thallasaemia trait has been shown ,in a small number of studies , to have a possible protective role against CAD and stroke.These kind of studies have been contacted in Greece also ,and usually they enroll a small number of participants. In the study, investigators will enroll 2500 subjects who serve in military units in Thesally Greece. Firstly investigators will estimate the prevalence of thallasaemia trait in this population , as it is very high in this region and at the same time investigators will retrospectively record data from their personal files (which are annually recorded).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GrThalasaemia | – | –estimation of IMT of the carotides arteries and calcium scoring |
| GrNormal | – | –estimation of IMT of the carotides arteries and calcium scoring |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 2500 subjects who serve in military units in Thessaly Greece
Key inclusion criteria (2 listed)
- voluntary participation,
- Subjects with Thalassemia treat will be confirmed of their treat by electrophoresis -
Key exclusion criteria (1 listed)
- -
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
Cardioprotective role of Thalassemia Treat
Time frame: 1 YEAR
Cardioprotective role of Thalassemia Treat
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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. This study is not recruiting at the moment.
Elias Andreanidis, PhD principal investigator
404 General Military Hospital, Larissa
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 Beta-Thalassemia Trait and Coronary Artery Disease, run by 404 General Military Hospital, Larissa 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 2 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: status not confirmed, as of the sponsor's last update on 11 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elias Andreanidis, PhD (+3 6944570406, elandreanides@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardioprotective role of Thalassemia Treat (time frame: 1 YEAR). 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 11 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.