Effect of Contouring Techniques on CMR Assessment of the Right Ventricle in Repaired Tetraology of Fallot

• Conditions: Tetralogy of Fallot
• Interventions: Diagnostic Test: Cardiac MRI

• Registration Number: NCT04359940
• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust

Brief Summary

Patients with repaired tetralogy of Fallot (RTOF) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. The investigators sought to determine whether the choice of myocardial contouring technique affects preoperative RV volumetric thresholds for intervention.

Detailed Description

Participants with repaired tetralogy of Fallot (RTOF) will be identified using existing patient electronic records who have developed chronic pulmonary regurgitation and are undergoing monitoring for right ventricular dilatation. Cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. There are different post-processing techniques published for measuring RV volumes on cardiac magnetic resonance imaging (detailed vs. smoothed and manual vs. automated). The primary aim of this study is to identify whether the choice of myocardial contouring technique affects the preoperative RV volumetric thresholds for intervention. As a secondary aim, the investigators will determine the reproducibility of different contouring methods.

Study Timeline

• Study Start: 2013-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-13
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Consecutive patients with repaired Tetralogy of Fallot undergoing routine clinical surveillance at a Level 1 ACHD surgical referral centre.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Repaired Tetralogy of Fallot	Cardiac MRI	Patients undergoing routine clinical aand CMR surveillance

Primary Outcome Measures

Name	Time	Method
Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique	Cross-sectional study. Repeated measurements performed on the baseline CMR study.	Measurements of indexed right ventricular end-diastolic volume will be repeated using different contouring techniques on the same cardiac MRI study performed at baseline pre-surgery.

Trial Locations

Locations (2)

Cardiac MRI department, University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

QEHB; 🇬🇧 Birmingham, United Kingdom