B-Thalasaemia Trait and Its Possible Cardioprotective Role | NCT02428023

Studies
B-Thalasaemia Trait and Its Possible Cardioprotective Role

NCT02428023

Sponsor

404 General Military Hospital, Larissa

Status

Unknown status

Last Update Posted

Jan 11, 2016Estimated

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Beta-Thalassemia Trait
Coronary Artery Disease

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

Apr 28, 2015Estimated

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

Jan 8, 2016

Last Update Posted Date

Jan 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ANDREANIDIS ELIAS, Director of Cardiology Department, 404 General Military Hospital, LarissaPrincipal Investigator

Lead Sponsor

404 General Military Hospital, LarissaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GrThalasaemia		estimation of IMT of the carotides arteries and calcium scoring
GrNormal		estimation of IMT of the carotides arteries and calcium scoring

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardioprotective role of Thalassemia Treat	Cardioprotective role of Thalassemia Treat	1 YEAR

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

voluntary participation,
Subjects with Thalassemia treat will be confirmed of their treat by electrophoresis -

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

57 Years

Standard Ages

Adult

Study Population

2500 subjects who serve in military units in Thessaly Greece

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elias Andreanidis, PhD	Contact	+3 6944570406		elandreanides@gmail.com
Maria Malliarou, PhD	Contact	+3 6944796499		mmalliarou@gmail.com

Overall Officials

Name	Affiliation	Role
Elias Andreanidis, PhD	404 General Military Hospital, Larissa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
404 Military Hospital	Recruiting	Larissa			Greece

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D013789	Thalassemia
D020521	Stroke

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided