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

• ClinicalTrials.gov Identifier: NCT01678274
• Recruitment Status: Unknown
• First Posted: September 3, 2012
• Last Update Posted: May 24, 2016
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Tracking Information

• First Submitted Date: August 30, 2012
• First Posted Date: September 3, 2012
• Last Update Posted Date: May 24, 2016
• Study Start Date: December 2013
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2013)

• 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

Original Primary Outcome Measures (submitted: August 30, 2012)

• 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 distensibillity [ Time Frame: Once ]
  Aortic distensibillity as measured by MRI

Current Secondary Outcome Measures (submitted: August 30, 2012)

• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 30, 2012)

echocardiography [ Time Frame: Once ]

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Prospective Characterization of the Heart, Aorta and Blood Pressure in Turner Syndrome. Association With Aortic Dissection.
• Official Title: Prospective Characterization of the Heart, Aorta and Blood Pressure in Women With Turner Syndrome. Association With Aortic Dissection.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood Serum

• 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.

Condition

• Turner Syndrome
• Aortic Aneurysm
• Ischemic Heart Disease
• Hypertension
• Congenital Heart Defect

• Intervention: Not Provided

Study Groups/Cohorts

• Turner syndrome
  Females with Turner syndrome
• Control group
  age matched females acting as controls

Publications *

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: May 23, 2016): 106
• Original Estimated Enrollment (submitted: August 30, 2012): 170
• Estimated Study Completion Date: October 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01678274
• Other Study ID Numbers: 35202
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Aarhus
• Study Sponsor: University of Aarhus
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Aarhus
• Verification Date: June 2015