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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2025-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Transposition of Great Arteries

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes