Overview

This trial is active, not recruiting.

Conditions turner syndrome, aortic aneurysm, ischemic heart disease, hypertension, congenital heart defect
Sponsor University of Aarhus
Start date December 2013
End date March 2016
Trial size 106 participants
Trial identifier NCT01678274, 35202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Females with Turner syndrome
age matched females acting as controls

Primary Outcomes

Measure
Aortic dimensions
time frame: Once
Agatston score
time frame: Once
Segment involvement score
time frame: Once
Aortic distensibility
time frame: Once

Secondary Outcomes

Measure
24 hour blood pressure
time frame: 24 hour
Pulse Wave Velocity
time frame: Once
Augmentation index
time frame: Once
Central blood pressure
time frame: Once

Eligibility Criteria

Female participants from 18 years up to 90 years old.

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

Additional Information

Official title Prospective Characterization of the Heart, Aorta and Blood Pressure in Women With Turner Syndrome. Association With Aortic Dissection.
Principal investigator Christian Trolle, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.