Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascu... | NCT06178887

Studies
Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascular Anomalies in Adult Patients with Turner Syndrome

NCT06178887

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Status

Recruiting

Last Update Posted

Mar 14, 2025Actual

Enrollment

33Estimated

Phase

Not provided

Conditions

Anomaly Heart
Turner Syndrome

Interventions

imaging

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2019Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 27, 2023

First Submission Date that Met QC Criteria

Dec 11, 2023

First Posted Date

Dec 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2025

Last Update Posted Date

Mar 14, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincenzo Rochira, Prof., Azienda Ospedaliero-Universitaria di ModenaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliero-Universitaria di ModenaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Estimated

Name	Type	Description	Arm Group Labels	Other Names
imaging	Diagnostic Test	cardiac angioMR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

confirmed diagnosis of Turner Syndrome
patients underwent angioMR 1.5 T
age > 18 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

cohort of patients with Turner syndrome > 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincenzo Rochira, Prof.	Contact	0593961829		vincenzo.rochira@unimore.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unit of Endocrinology of Azienda Ospedaliera-Universitaria di Modena	Recruiting	Modena			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital
D014424	Turner Syndrome

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003952	Diagnostic Imaging

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided