Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV) — RESTORE-HV

Left Atrial Fibrosis Clinical Trial

Official title:
GIMIAS® Tool Validation for the Detection of Left Atrium Fibrosis Through Late Enhancement Magnetic Resonance Image Processing. Pattern Determination in a Cohort of Healthy Volunteers

Status Completed

Clinical Trial Summary

The purpose of this study is to validate the technique for the detection of left atrial fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.

Clinical Trial Description

3D reconstructions obtained by GIMIAS® will be evaluated. Processing images will be carried out by two independent operators, and will calculate the kappa interobserver agreement .

Subsequently, the processed images are compared with images previously obtained in 10 patients with persistent atrial fibrillation adjusted for sex and age. A qualitative visual comparison will be made. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02274246
Study type	Interventional
Source	Fundacion Clinic per a la Recerca Biomédica
Contact
Status	Completed
Phase	Phase 1
Start date	November 2014
Completion date	March 2015

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