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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00624949
Other study ID # 20010248
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 19, 2008
Last updated February 27, 2008
Start date August 2003
Est. completion date June 2012

Study information

Verified date February 2008
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

An observational study of 102 women with Turner syndrome followed for 6 years with a two-yearly examination including ECHO, MRI of the heart and 24 ambulatory blood pressure. It has been found that besides an significantly increased risk of congenital cardiac malformations, TS have an increased risk of developing cardiac disease including the life threatening condition of aortic dilatation and rupture. The aim of the study is to describe the cardiac conditions of TS, evaluate different methods of examination and identify possible risc factors.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 102
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Turner syndrome

- Age 18-70 years

Exclusion Criteria:

- Extreme adipositas

- Contraindications to a MRI scan

- Malignant disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Outcome

Type Measure Description Time frame Safety issue
Primary Aortic diameter at 3 well-defined levels measured by MRI and ECHO 2-yearly for 6 years No
Secondary 24hour ambulatory blood pressure 24h 2-yearly for 6 years No
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