- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00624949
Aortic Dimensions in Turner Syndrome
February 27, 2008 updated by: University of Aarhus
Aortic Dimensions, 24hour Ambulatory Blood Pressure and Sympathovagal Tone in Turner Syndrome. In Relation to Aortic Dilatation and Dissection.
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Actual)
102
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Recrutted from hospital clinics and through the patient organisation
Description
Inclusion Criteria:
- Turner syndrome
- Age 18-70 years
Exclusion Criteria:
- Extreme adipositas
- Contraindications to a MRI scan
- Malignant disease
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
1
women with Turner syndrome
|
2.
Control women
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Aortic diameter at 3 well-defined levels measured by MRI and ECHO
Time Frame: 2-yearly for 6 years
|
2-yearly for 6 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24hour ambulatory blood pressure
Time Frame: 24h 2-yearly for 6 years
|
24h 2-yearly for 6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Trolle C, Mortensen KH, Bjerre M, Hougaard DM, Cohen A, Andersen NH, Gravholt CH. Osteoprotegerin in Turner syndrome - relationship to aortic diameter. Clin Endocrinol (Oxf). 2015 Mar;82(3):397-403. doi: 10.1111/cen.12522. Epub 2014 Jul 2.
- Trolle C, Mortensen KH, Pedersen LN, Berglund A, Jensen HK, Andersen NH, Gravholt CH. Long QT interval in Turner syndrome--a high prevalence of LQTS gene mutations. PLoS One. 2013 Jul 25;8(7):e69614. doi: 10.1371/journal.pone.0069614. Print 2013.
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
August 1, 2003
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 27, 2008
First Posted (Estimate)
February 28, 2008
Study Record Updates
Last Update Posted (Estimate)
February 28, 2008
Last Update Submitted That Met QC Criteria
February 27, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Endocrine System Diseases
- Disease
- Gonadal Disorders
- Disorders of Sex Development
- Urogenital Abnormalities
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Chromosome Disorders
- Sex Chromosome Disorders
- Sex Chromosome Disorders of Sex Development
- Syndrome
- Turner Syndrome
- Gonadal Dysgenesis
Other Study ID Numbers
- 20010248
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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