Skip to main content
Clinical Trials/NCT04359940
NCT04359940
Unknown
Not Applicable

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

University Hospital Birmingham NHS Foundation Trust2 sites in 1 country30 target enrollmentJanuary 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tetralogy of Fallot
Sponsor
University Hospital Birmingham NHS Foundation Trust
Enrollment
30
Locations
2
Primary Endpoint
Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
April 14, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Birmingham NHS Foundation Trust
Responsible Party
Principal Investigator
Principal Investigator

William E Moody

Consultant Cardiologist

University Hospital Birmingham NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Difference in the baseline measurement of indexed right ventricular end-diastolic volume according to the contouring technique

Time Frame: 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.

Study Sites (2)

Loading locations...

Similar Trials