Trial record 13 of 1684 for:
heart disease and women
Prospective Characterization of the Heart, Aorta and Blood Pressure in Turner Syndrome. Association With Aortic Dissection. (TSCORII)
This study is not yet open for participant recruitment.
Verified January 2013 by University of Aarhus
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01678274
First received: August 30, 2012
Last updated: January 9, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
persistent Müllerian duct syndrome
tetrasomy 18p
Turner syndrome
MedlinePlus related topics:
Aneurysms
Aortic Aneurysm
Congenital Heart Defects
Coronary Artery Disease
Heart Diseases
High Blood Pressure
Turner Syndrome
U.S. FDA Resources
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: | February 2013 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (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
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 | Not yet 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: | January 9, 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 Vascular Diseases Cardiovascular Diseases Aortic Diseases Coronary Disease Arterial Occlusive Diseases Disorders of Sex Development Sex Chromosome Disorders of Sex Development Sex Chromosome Disorders Chromosome Disorders Genetic Diseases, Inborn Gonadal Disorders Endocrine System Diseases |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Aneurysm Aortic Aneurysm Myocardial Ischemia Hypertension Ischemia Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Arteriosclerosis Cardiovascular Abnormalities Congenital Abnormalities Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013