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

Hypertension Clinical Trial

— TSCORII  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01678274
• Other study ID #: 35202
• Status: Active, not recruiting
• Phase: N/A
• First received: August 30, 2012
• Last updated: May 23, 2016
• Start date: December 2013
• Est. completion date: October 2016

Study information

• Verified date: June 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Aneurysm
• Congenital Heart Defect
• Coronary Artery Disease
• Gonadal Dysgenesis
• Heart Defects, Congenital
• Heart Diseases
• Hypertension
• Ischemic Heart Disease
• Myocardial Ischemia
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Locations

Country	Name	City	State
Denmark	Department of Endocrinology and Internal medicine	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	echocardiography	echocardiography evaluating Mitral and aortic valves, left ventricular hypertrophy, diastolic and systolic function etc..	Once	No
Primary	Aortic dimensions	Aortic dimensions measured by MRI	Once	No
Primary	Agatston score	Coronary CT evaluation of Agatston score	Once	No
Primary	Segment involvement score	Segment involvement score (SIS) calculated as the sum of segments with one or more coronary plaques (score 0-18).	Once	No
Primary	Aortic distensibility	Aortic distensibillity as measured by MRI	Once	No
Secondary	24 hour blood pressure	24 hour blood pressure	24 hour	No
Secondary	Pulse Wave Velocity	Pulse Wave Velocity measured by applanation tonometry.	Once	No
Secondary	Augmentation index	Augmentation index measured by applanation tonometry.	Once	No
Secondary	Central blood pressure	Central blood pressure measured by applanation tonometry.	Once	No