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NOT YET RECRUITING
NCT05916976
NA

Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment

Sponsor: University Medical Center Goettingen

View on ClinicalTrials.gov

Summary

Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. A new score will be used to summarize the multitude of MRI-based parameters into a single number. Individual modificators are assigned to the components of the score. The value of each modificatory will be determined as a result of this feasibility trial. This new compound score is designed to anticipate any deterioration of cardiac function, arrhythmias or sudden cardiac death. This feasibility study is the first step to establish this score and find initial values for the modifies that are assigned to the more than 40 biomarkers from MRI, clinical examinations and serum parameters that are included in this new score.

Official title: MRI in Repaired Tetralogy of Fallot: Risc Score Derived From Multiparametric Magnetic Resonance-Imaging and Clinical Data to Sharpen the Indication for Change of Individualized Treatment

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-10-15

Completion Date

2026-04-30

Last Updated

2023-06-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

cardiac MRI

Multiparametric MRI of the heart

Locations (1)

University Medical Center Goettingen

Göttingen, Lower Saxxony, Germany