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

NCT05690854 | Unknown DMC

• 1 other identifier: STAR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Transposition of Great Arteries

Outcome Measures

Primary Outcomes (1)

• Adverse Outcome definition

  A composite of death, hospitalizations for heart failure, cardiovascular arrest, sustained arrhythmias (≥30 seconds).

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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:

You may not qualify if:

• (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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Giulia Pasqualin, MD

CONTACT

+390252774502; giulia.pasqualin@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: November 29, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

IT (1)