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NCT05690854
Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)
Conditions: Transposition of Great Arteries
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 30
Sponsor: IRCCS Policlinico S. Donato
Location: Italy
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).
Eligibility Criteria
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 orare scheduled for a Cardiovascular Magnetic Resonance examination in this InstitutionControl 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 safetySubjects with non CMR-conditional devicesSubjects with claustrophobia or breath-holding precluding an adequate CMR and 4D Flow images qualityPregnant women
Source: ClinicalTrials.gov (NCT05690854). StuddyBuddy aggregates publicly available trial information.