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

Phase 1

Completed

• Conditions: Left Atrial Fibrosis
• Interventions: Drug: gadobutrol

• Registration Number: NCT02274246
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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.

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Study Start: 2014-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadobutrol	gadobutrol	Gadobutrol in Healthy volunteers

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index.	1 week after intervention
Adverse events	1 week after intervention

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain