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

Sponsor

University of Aarhus (Other)

Overall Status

Unknown status

CT.gov ID

NCT01678274

Collaborator

(none)

106

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

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 :

Dec 1, 2013

Actual Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Turner syndrome Females with Turner syndrome
Control group age matched females acting as controls

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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