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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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.