Effect of Contouring Techniques on CMR Assessment of the Right Ventricle in Repaired Tetraology of Fallot
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
1 other identifier
observational
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedApril 24, 2020
April 1, 2020
7.3 years
April 13, 2020
April 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Repaired Tetralogy of Fallot
Patients undergoing routine clinical aand CMR surveillance
Interventions
Eligibility Criteria
Patients with repaired tetralogy of Fallot (RTOF) with chronic pulmonary regurgitation who require monitoring for right ventricular dilatation.
You may qualify if:
- Consecutive patients with repaired Tetralogy of Fallot undergoing routine clinical surveillance at a Level 1 ACHD surgical referral centre.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
QEHB
Birmingham, B15 2TH, United Kingdom
Cardiac MRI department, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Moody
UHB
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Cardiologist
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 24, 2020
Study Start
January 1, 2013
Primary Completion
April 14, 2020
Study Completion
April 14, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share