Turner SyndromeTSCORIINCT01678274
Prospective Characterization of the Heart, Aorta and Blood Pressure in Turner Syndrome. Association With Aortic Dissection.
An observational study of Turner Syndrome and Aortic Aneurysm, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner Syndrome, Aortic Aneurysm, Ischemic Heart Disease
- How many people
- 106 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Characterization of the Heart, Aorta and Blood Pressure in Women With Turner Syndrome. Association With Aortic Dissection.
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.
Read the 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.
- Conditions
- Turner Syndrome, Aortic Aneurysm, Ischemic Heart Disease, Hypertension, Congenital Heart Defect
- Keywords
- Turner Syndrome, Aortic Aneurysm, Ischemic heart disease, Hypertension, Congenital Heart Defect, Pulse Wave Velocity, Augmentation Index, Central Blood Pressure, Agatston Score, Segment involvement score
- Medical subject headings
- Turner Syndrome, Aortic Aneurysm, Myocardial Ischemia, Hypertension, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Turner syndrome | Females with Turner syndrome | |
| Control group | age matched females acting as controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic dimensions
Aortic dimensions measured by MRI
Measured: Once
Agatston score
Coronary CT evaluation of Agatston score
Measured: Once
Segment involvement score
Segment involvement score (SIS) calculated as the sum of segments with one or more coronary plaques (score 0-18).
Measured: Once
Aortic distensibility
Aortic distensibillity as measured by MRI
Measured: Once
Secondary outcomes (4)
24 hour blood pressure
24 hour blood pressure
Measured: 24 hour
Pulse Wave Velocity
Pulse Wave Velocity measured by applanation tonometry.
Measured: Once
Augmentation index
Augmentation index measured by applanation tonometry.
Measured: Once
Central blood pressure
Central blood pressure measured by applanation tonometry.
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus H Gravholt, MD, Study chair, Aarhus University HospitalChristian Trolle, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678274
- Sponsor's protocol ID
- 35202
- Acronym
- TSCORII
- Status last verified
- Jun 2015
- First submitted
- 30 Aug 2012
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ridder LO, Stochholm K, Mortensen KH, Andersen NH, Gravholt CH. The TGFbeta system and TIMP1 and 3 genotypes in Turner syndrome-Relation with aortic congenital malformations. Clin Endocrinol (Oxf). 2023 Dec;99(6):545-551. doi: 10.1111/cen.14907. Epub 2023 Mar 15.
PubMed 36890688Viuff MH, Just J, Brun S, Dam TV, Hansen M, Melgaard L, Hougaard DM, Lappe M, Gravholt CH. Women With Turner Syndrome Are Both Estrogen and Androgen Deficient: The Impact of Hormone Replacement Therapy. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1983-1993. doi: 10.1210/clinem/dgac167.
PubMed 35302622Wen 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.
PubMed 30541571Subramaniam 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.
PubMed 28231838
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Characterization of the Heart, Aorta and Blood Pressure in Women With Turner Syndrome. Association With Aortic Dissection.
- ClinicalTrials.gov ID
- NCT01678274
- Acronym / sponsor ID
- TSCORII / 35202
- Conditions
- Turner Syndrome, Aortic Aneurysm, Ischemic Heart Disease, Hypertension, Congenital Heart Defect
- Keywords
- Turner Syndrome, Aortic Aneurysm, Ischemic heart disease, Hypertension, Congenital Heart Defect, Pulse Wave Velocity, Augmentation Index, Central Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turner syndrome | – | –Females with Turner syndrome |
| Control group | – | –age matched females acting as controls |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
24 hour blood pressure
Time frame: 24 hour
Pulse Wave Velocity
Time frame: Once
Augmentation index
Time frame: Once
Central blood pressure
Time frame: Once
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Derived from this study: PubMed 36890688Ridder LO, Stochholm K, Mortensen KH, Andersen NH, Gravholt CH. The TGFbeta system and TIMP1 and 3 genotypes in Turner syndrome-Relation with aortic congenital malformations. Clin Endocrinol (Oxf). 2023 Dec;99(6):545-551. doi: 10.1111/cen.14907. Epub 2023 Mar 15.
- Derived from this study: PubMed 35302622Viuff MH, Just J, Brun S, Dam TV, Hansen M, Melgaard L, Hougaard DM, Lappe M, Gravholt CH. Women With Turner Syndrome Are Both Estrogen and Androgen Deficient: The Impact of Hormone Replacement Therapy. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1983-1993. doi: 10.1210/clinem/dgac167.
- Derived from this study: PubMed 30541571Wen 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.
- Derived from this study: PubMed 28231838Subramaniam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus H Gravholt, MD study chair
Aarhus University Hospital
Christian Trolle, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Turner Syndrome and Aortic Aneurysm, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic dimensions (time frame: Once). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01678274, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.