Anomaly HeartNCT06178887
Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascular Anomalies in Adult Patients with Turner Syndrome
An observational study of Anomaly Heart and Turner Syndrome, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anomaly Heart, Turner Syndrome
- What is being tested?
- imaging
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: cohort of patients with Turner syndrome > 18 years
Who may be able to join
- confirmed diagnosis of Turner Syndrome
- patients underwent angioMR 1.5 T
- age > 18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Endocrinology of Azienda Ospedaliera-Universitaria di Modena
Modena
Vincenzo Rochira, Prof., 0593962453, vincenzo.rochira@unimore.it
About this study
Official title: Role of Cardiac Magnetic Resonance Angiography (1.5-T) in the Diagnosis of Cardiac and Thoraco-abdominal Vascular Tree Anomalies in Adult Patients with Turner Syndrome
Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and MRI are interrupted at the diaphragmatic level.
- Conditions
- Anomaly Heart, Turner Syndrome
- Being tested
- imaging
- Medical subject headings
- Heart Defects, Congenital, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
cardiac angioMR
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular and cardiac anomalies
description of the main cardiovascular anomalies found by MRI at the thoracic and abdominal level anomalies in terms of supernumeray arteries and/or veins and measurement of length and diameters of main vascular tracts (e.g. ascending, descending aorta, aortic arch, renal arteries...) or vascular congenital abnormalities
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start8 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomaly HeartStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178887
- Sponsor's protocol ID
- 1001
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cardiac Magnetic Resonance Angiography (1.5-T) in the Diagnosis of Cardiac and Thoraco-abdominal Vascular Tree Anomalies in Adult Patients with Turner Syndrome
- ClinicalTrials.gov ID
- NCT06178887
- Acronym / sponsor ID
- 1001
- Conditions
- Anomaly Heart, Turner Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Dec 2023 (actual)
- 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.
Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and MRI are interrupted at the diaphragmatic level.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cohort of patients with Turner syndrome > 18 years
Key inclusion criteria (3 listed)
- confirmed diagnosis of Turner Syndrome
- patients underwent angioMR 1.5 T
- age > 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imagingcardiac angioMR | Diagnostic test | – |
Primary outcome
Vascular and cardiac anomalies
Time frame: 5 years
description of the main cardiovascular anomalies found by MRI at the thoracic and abdominal level anomalies in terms of supernumeray arteries and/or veins and measurement of length and diameters of main vascular tracts (e.g. ascending, descending aorta, aortic arch, renal arteries...) or vascular congenital abnormalities
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 Anomaly Heart and Turner Syndrome, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Rochira, Prof. (0593961829, vincenzo.rochira@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular and cardiac anomalies (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2025.