Prospective Characterization of the Heart, Aorta and Blood Pressure in Turner Syndrome. Association With Aortic Dissection. (TSCORII)

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ClinicalTrials.gov Identifier: NCT01678274

Recruitment Status : Unknown

Verified June 2015 by University of Aarhus.
Recruitment status was: Active, not recruiting

First Posted : September 3, 2012

Last Update Posted : May 24, 2016

Sponsor:

Information provided by (Responsible Party):

University of Aarhus

Study Description

Brief Summary:

Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and autoimmune diseases in general.

Our study aim is:

Using MRI to further characterize and find risk factors leading to aortic dilation.
Using MRI to assess the degree of aortic distensibility.
Using Computed tomography x-ray scanning of the heart and coronary arteries to characterize the prevalence and degree of ischemic heart disease and coronary anomalies.
Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of aortic stiffness when compared to controls using end points as Pulse Wave Velocity, Augmentation Index and Central Pulse Pressure.

Condition or disease
Turner Syndrome Aortic Aneurysm Ischemic Heart Disease Hypertension Congenital Heart Defect

Detailed Description:

Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence of ischemic heart disease, aortic dilation and dissection, congenital heart defects, hypertension, stroke, ovarian failure, infertility, decreased final height and autoimmune diseases in general

Our study aim is:

Using MRI to further characterize and find risk factors leading to aortic dilation.
Using MRI to describe aortic dimensions
Using MRI to assess the degree of aortic distensibility.
Using Computed tomography x-ray scanning of the heart and coronary arteries to characterize the prevalence and degree of ischemic heart disease and coronary anomalies.
Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of aortic stiffness when compared to controls using end points as Pulse Wave Velocity, Augmentation Index and Central Pulse Pressure.

Study Design

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Study Type :	Observational
Actual Enrollment :	106 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Prospective Characterization of the Heart, Aorta and Blood Pressure in Women With Turner Syndrome. Association With Aortic Dissection.
Study Start Date :	December 2013
Actual Primary Completion Date :	March 2016
Estimated Study Completion Date :	October 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Turner syndrome Hypertension

MedlinePlus related topics: Primary Ovarian Insufficiency Turner Syndrome

Genetic and Rare Diseases Information Center resources: Gonadal Dysgenesis Turner Syndrome

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Turner syndrome Females with Turner syndrome
Control group age matched females acting as controls

Outcome Measures

Primary Outcome Measures :

Aortic dimensions [ Time Frame: Once ]
Aortic dimensions measured by MRI
Agatston score [ Time Frame: Once ]
Coronary CT evaluation of Agatston score
Segment involvement score [ Time Frame: Once ]
Segment involvement score (SIS) calculated as the sum of segments with one or more coronary plaques (score 0-18).
Aortic distensibility [ Time Frame: Once ]
Aortic distensibillity as measured by MRI

Secondary Outcome Measures :

24 hour blood pressure [ Time Frame: 24 hour ]
24 hour blood pressure
Pulse Wave Velocity [ Time Frame: Once ]
Pulse Wave Velocity measured by applanation tonometry.
Augmentation index [ Time Frame: Once ]
Augmentation index measured by applanation tonometry.
Central blood pressure [ Time Frame: Once ]
Central blood pressure measured by applanation tonometry.

Other Outcome Measures:

echocardiography [ Time Frame: Once ]
echocardiography evaluating Mitral and aortic valves, left ventricular hypertrophy, diastolic and systolic function etc..

Biospecimen Retention: Samples With DNA

Blood Serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Females with Turner Syndrome previously participating in our study number 2001024 are recruited from out-patient clinics.

Controls are healthy volunteers recruited from the general population by advertisement.

Criteria

Inclusion Criteria with respect to individuals acting as controls:

Healthy age matched females

Exclusion Criteria:

Contraindications for MRI
Contraindications for CT
Severe obesity
Acute og Chronic disease with known or presumed significance with concern to outcomes of the study
Previous or present malignant disease
Clinically significant liver disease
Mechanic or biological heart valves

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678274

Locations

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Denmark
Department of Endocrinology and Internal medicine
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

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Study Chair:	Claus H Gravholt, MD	Aarhus University Hospital
Principal Investigator:	Christian Trolle, MD	Aarhus University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wen J, Trolle C, Viuff MH, Ringgaard S, Laugesen E, Gutmark EJ, Subramaniam DR, Backeljauw P, Gutmark-Little I, Andersen NH, Mortensen KH, Gravholt CH. Impaired aortic distensibility and elevated central blood pressure in Turner Syndrome: a cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2018 Dec 13;20(1):80. doi: 10.1186/s12968-018-0497-0.

Subramaniam DR, Stoddard WA, Mortensen KH, Ringgaard S, Trolle C, Gravholt CH, Gutmark EJ, Mylavarapu G, Backeljauw PF, Gutmark-Little I. Continuous measurement of aortic dimensions in Turner syndrome: a cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2017 Feb 24;19(1):20. doi: 10.1186/s12968-017-0336-8.

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Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01678274 History of Changes
Other Study ID Numbers:	35202
First Posted:	September 3, 2012 Key Record Dates
Last Update Posted:	May 24, 2016
Last Verified:	June 2015

Keywords provided by University of Aarhus:


Turner Syndrome Aortic Aneurysm Ischemic heart disease Hypertension Congenital Heart Defect	Pulse Wave Velocity Augmentation Index Central Blood Pressure Agatston Score Segment involvement score

Additional relevant MeSH terms:

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Syndrome Hypertension Heart Diseases Aneurysm Aortic Aneurysm Myocardial Ischemia Coronary Artery Disease Aneurysm, Dissecting Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Heart Defects, Congenital Disease Pathologic Processes Vascular Diseases	Cardiovascular Diseases Aortic Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Cardiovascular Abnormalities Congenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Genetic Diseases, Inborn Gonadal Disorders Endocrine System Diseases

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