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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01678274
First received: August 30, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Characterization of the Heart, Aorta and Blood Pressure in Women With Turner Syndrome. Association With Aortic Dissection.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Aortic dimensions [ Time Frame: Once ] [ Designated as safety issue: No ]
    Aortic dimensions measured by MRI

  • Agatston score [ Time Frame: Once ] [ Designated as safety issue: No ]
    Coronary CT evaluation of Agatston score

  • Segment involvement score [ Time Frame: Once ] [ Designated as safety issue: No ]
    Segment involvement score (SIS) calculated as the sum of segments with one or more coronary plaques (score 0-18).

  • Aortic distensibility [ Time Frame: Once ] [ Designated as safety issue: No ]
    Aortic distensibillity as measured by MRI


Secondary Outcome Measures:
  • 24 hour blood pressure [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    24 hour blood pressure

  • Pulse Wave Velocity [ Time Frame: Once ] [ Designated as safety issue: No ]
    Pulse Wave Velocity measured by applanation tonometry.

  • Augmentation index [ Time Frame: Once ] [ Designated as safety issue: No ]
    Augmentation index measured by applanation tonometry.

  • Central blood pressure [ Time Frame: Once ] [ Designated as safety issue: No ]
    Central blood pressure measured by applanation tonometry.


Other Outcome Measures:
  • echocardiography [ Time Frame: Once ] [ Designated as safety issue: No ]
    echocardiography evaluating Mitral and aortic valves, left ventricular hypertrophy, diastolic and systolic function etc..


Biospecimen Retention:   Samples With DNA

Blood Serum


Estimated Enrollment: 170
Study Start Date: December 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Turner syndrome
Females with Turner syndrome
Control group
age matched females acting as controls

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678274

Contacts
Contact: Christian Trolle, MD +45 6133 9269 Christian.Trolle@ki.au.dk
Contact: Claus H Gravholt, MD +45 7846 9977 claus.gravholt@ki.au.dk

Locations
Denmark
Department of Endocrinology and Internal medicine Recruiting
Aarhus, Denmark, 8000
Contact: Christian Trolle, MD    +45 6133 9269    Christian.Trolle@KI.AU.DK   
Contact: Claus H Gravholt, MD    + 45 7846 9977    Claus.Gravholt@KI.AU.DK   
Principal Investigator: Christian Trolle, MD         
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Claus H Gravholt, MD Aarhus University Hospital
Principal Investigator: Christian Trolle, MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01678274     History of Changes
Other Study ID Numbers: 35202
Study First Received: August 30, 2012
Last Updated: December 19, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Turner Syndrome
Aortic Aneurysm
Ischemic heart disease
Hypertension
Congenital Heart Defect
Pulse Wave Velocity
Augmentation Index
Central Blood Pressure
Agatston Score
Segment involvement score

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Defects, Congenital
Heart Diseases
Adnexal Diseases
Aortic Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Chromosome Disorders
Coronary Disease
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Vascular Diseases
Aneurysm
Aortic Aneurysm
Gonadal Dysgenesis
Hypertension
Myocardial Ischemia
Primary Ovarian Insufficiency
Syndrome
Turner Syndrome
Arteriosclerosis
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 22, 2014