Aortic Dimensions in Turner Syndrome - Full Text View

Sponsor:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00624949

Purpose

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.

Condition
Turner Syndrome

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Aortic Dimensions, 24hour Ambulatory Blood Pressure and Sympathovagal Tone in Turner Syndrome. In Relation to Aortic Dilatation and Dissection.

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome persistent Müllerian duct syndrome tetrasomy 18p Turner syndrome

MedlinePlus related topics: Turner Syndrome

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Aortic diameter at 3 well-defined levels measured by MRI and ECHO [ Time Frame: 2-yearly for 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

24hour ambulatory blood pressure [ Time Frame: 24h 2-yearly for 6 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Blood samples

Enrollment:	102
Study Start Date:	August 2003
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 women with Turner syndrome
2. Control women

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Recrutted from hospital clinics and through the patient organisation

Criteria

Inclusion Criteria:

Turner syndrome
Age 18-70 years

Exclusion Criteria:

Extreme adipositas
Contraindications to a MRI scan
Malignant disease

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Professor Jens Sandahl Christiansen, Aarhus University Hospital, Aarhus, Denmark
ClinicalTrials.gov Identifier:	NCT00624949 History of Changes
Other Study ID Numbers:	20010248
Study First Received:	February 19, 2008
Last Updated:	February 27, 2008
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Turner syndrome
aortic dimensions
blood pressure
aortic dilatation
aortic rupture

Additional relevant MeSH terms:

Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012