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

• Conditions: Turner Syndrome; Hypertension; Aortic Aneurysm; Ischemic Heart Disease; Congenital Heart Defect

• Registration Number: NCT01678274
• Lead Sponsor: University of Aarhus

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-03
• Study Start: 2013-12
• Status Verified: 2015-06
• Primary Completion: 2016-03
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 106

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aortic distensibility	Once	Aortic distensibillity as measured by MRI
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).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Endocrinology and Internal medicine; 🇩🇰 Aarhus, Denmark