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

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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):

Study Description
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.

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

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 Design

Study Type : Observational
Actual Enrollment : 106 participants
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.
Study Start Date : December 2013
Primary Completion Date : March 2016
Estimated Study Completion Date : October 2016


Groups and Cohorts

Group/Cohort
Turner syndrome
Females with Turner syndrome
Control group
age matched females acting as controls


Outcome Measures

Primary Outcome Measures :
  1. Aortic dimensions [ Time Frame: Once ]
    Aortic dimensions measured by MRI

  2. Agatston score [ Time Frame: Once ]
    Coronary CT evaluation of Agatston score

  3. 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).

  4. Aortic distensibility [ Time Frame: Once ]
    Aortic distensibillity as measured by MRI


Secondary Outcome Measures :
  1. 24 hour blood pressure [ Time Frame: 24 hour ]
    24 hour blood pressure

  2. Pulse Wave Velocity [ Time Frame: Once ]
    Pulse Wave Velocity measured by applanation tonometry.

  3. Augmentation index [ Time Frame: Once ]
    Augmentation index measured by applanation tonometry.

  4. Central blood pressure [ Time Frame: Once ]
    Central blood pressure measured by applanation tonometry.


Other Outcome Measures:
  1. echocardiography [ Time Frame: Once ]
    echocardiography evaluating Mitral and aortic valves, left ventricular hypertrophy, diastolic and systolic function etc..


Biospecimen Retention:   Samples With DNA
Blood Serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678274


Locations
Denmark
Department of Endocrinology and Internal medicine
Aarhus, Denmark, 8000
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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01678274     History of Changes
Other Study ID Numbers: 35202
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: June 2015

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:
Syndrome
Hypertension
Heart Diseases
Aneurysm
Aortic Aneurysm
Myocardial Ischemia
Coronary Artery Disease
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Heart Defects, Congenital
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Cardiovascular Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases