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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05690854
Acronym
STAR
Enrollment
30
Registered
2023-01-19
Start date
2022-11-29
Completion date
2025-06-30
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transposition of Great Arteries

Brief summary

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).

Interventions

None listed

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse Outcome definition5 yearsA composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).

Countries

Italy

Contacts

Primary ContactGiulia Pasqualin, MD
giulia.pasqualin@grupposandonato.it+390252774502

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026