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

Tetralogy of Fallot Clinical Trial

Official title:

The Effect of Different Contouring Techniques on Cardiac Magnetic Resonance Assessment of Right Ventricular Volumes in Repaired Tetraology of Fallot: Implications on Preoperative Thresholds for Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04359940
• Other study ID #: CARMS
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: April 14, 2020

Study information

• Verified date: April 2020
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: Freya Lodge
• Email: freya.lodge[@]uhb.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 14, 2020
• Est. primary completion date: April 14, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Tetralogy of Fallot

Intervention

Diagnostic Test:
• Cardiac MRI
For clinical surveillance

Locations

Country	Name	City	State
United Kingdom	Cardiac MRI department, University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	QEHB	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique	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.	Cross-sectional study. Repeated measurements performed on the baseline CMR study.