Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR) (STAR)

January 20, 2023 updated by: Giulia Pasqualin, IRCCS Policlinico S. Donato

Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR): From Pathophysiology to Clinical Application

The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of L-loop transposition of great arteries (L-TGA) and D-loop transposition of great arteries (D-TGA) after atrial switch operation (ASO).

Description

Inclusion Criteria:Case group:

The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:

  • are admitted to UNICCA, the Adult Congenital Heart Unit or
  • are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution

Control group:

The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.

Exclusion Criteria:

  • (case and control group)

    • Subjects with intrabody ferromagnetic material precluding subject's safety
    • Subjects with non CMR-conditional devices
    • Subjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images quality
    • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Case

The study will include patients aged ≥ 18 years with the diagnosis of L-TGA and D-TGA, who:

  • are admitted to IRCCS Policlinico San Donato, the Adult Congenital Heart Unit or
  • are scheduled for a Cardiovascular Magnetic Resonance examination in this Institution
Control
The study will include subjects aged ≥ 18 years who will invited for a Cardiovascular Magnetic Resonance examination in our Institution. This group of control will include n=15 of adult healthy subjects. A further inclusion criteria for the control subjects are age and male proportion comparable to those of the TGA group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Outcome definition
Time Frame: 5 years
A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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