- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02428023
B-Thalasaemia Trait and Its Possible Cardioprotective Role
January 8, 2016 updated by: ANDREANIDIS ELIAS, 404 General Military Hospital, Larissa
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
2500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Larissa, Greece
- Recruiting
- 404 Military Hospital
-
Contact:
- ELIAS ANDREANIDES, PhD
- Phone Number: +3 6944570406
- Email: elandreanides@gmail.com
-
Contact:
- Maria Malliarou, PhD
- Email: mmalliarou@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 57 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
2500 subjects who serve in military units in Thessaly Greece
Description
Inclusion Criteria:
- voluntary participation,
- Subjects with Thalassemia treat will be confirmed of their treat by electrophoresis -
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
GrThalasaemia
estimation of IMT of the carotides arteries and calcium scoring
|
GrNormal
estimation of IMT of the carotides arteries and calcium scoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardioprotective role of Thalassemia Treat
Time Frame: 1 YEAR
|
Cardioprotective role of Thalassemia Treat
|
1 YEAR
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elias Andreanidis, PhD, 404 General Military Hospital, Larissa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
April 23, 2015
First Submitted That Met QC Criteria
April 27, 2015
First Posted (Estimate)
April 28, 2015
Study Record Updates
Last Update Posted (Estimate)
January 11, 2016
Last Update Submitted That Met QC Criteria
January 8, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Coronary Disease
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Coronary Artery Disease
- Thalassemia
- beta-Thalassemia
Other Study ID Numbers
- 404 General Military Hospital
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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