Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678274
Recruitment Status : Unknown
Verified June 2015 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : September 3, 2012
Last Update Posted : May 24, 2016
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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