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

NCT ID: NCT04359940

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2020-04-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tetralogy of Fallot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Repaired Tetralogy of Fallot

Patients undergoing routine clinical aand CMR surveillance

Cardiac MRI

Intervention Type DIAGNOSTIC_TEST

For clinical surveillance

Interventions

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Cardiac MRI

For clinical surveillance

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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William E Moody

Consultant Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Moody

Role: PRINCIPAL_INVESTIGATOR

UHB

Locations

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QEHB

Birmingham, , United Kingdom

Site Status RECRUITING

Cardiac MRI department, University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Freya Lodge

Role: CONTACT

[email protected]

William Moody

Role: CONTACT

[email protected]

Facility Contacts

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William E Moody

Role: primary

[email protected]
+447736275032

Freya Lodge

Role: primary

[email protected]

Other Identifiers

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CARMS

Identifier Type: -

Identifier Source: org_study_id

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