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

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02274246

Acronym

RESTORE-HV

Enrollment

Registered

2014-10-24

Start date

2014-11-30

Completion date

2015-03-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Atrial Fibrosis

Keywords

Segmentation, GIMIAS® program, Atrial fibrillation, Left atrial fibrosis, Healthy volunteers

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.

Interventions

DRUGgadobutrol

Gadobutrol administration in healthy volunteers

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026