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

Fundacion Clinic per a la Recerca Biomédica

Status and phase

Completed

Phase 1

Conditions

Left Atrial Fibrosis

Treatments

Drug: gadobutrol

Study type

Interventional

Funder types

Other

Identifiers

NCT02274246

RESTORE-HV

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.