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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Left Atrial Fibrosis

Intervention / Treatment
-----------------
* Drug: gadobutrol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers capable of being subjected to the prespecified tests of the study. Healthy volunteers that sign the informed consent after being informed. Exclusion Criteria: Healthy volunteers with: A medical history of atrial fibrillation, hypertension or diabetes mellitus. A medical history of heart disease, structural, ischemic or arrhythmic. A medical history of chronic obstructive pulmonary disease/obstructive sleep apnoea/hypopnoea syndrome Sport habits: intense sport activities during three or more hours in a week Any assumption that contraindicates the magnetic resonance and/or the use of gadolinium or other contrast mediums, including a medical history of previous allergic or not allergic reactions with the use of gadolinium or other contrast mediums, bronchial asthma or allergic diseases. Pregnancy or breast feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gadobutrol<br>Gadobutrol in Healthy volunteers | Drug: gadobutrol<br>* Gadobutrol administration in healthy volunteers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS. |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 1 week after intervention | 
| Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index. |  | 1 week after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Segmentation, GIMIAS® program, Atrial fibrillation, Left atrial fibrosis, Healthy volunteers