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

Sponsor

Fundacion Clinic per a la Recerca Biomédica (Other)

Overall Status

Completed

CT.gov ID

NCT02274246

Collaborator

(none)

Enrollment

Location

Arm

3.9

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Atrial Fibrosis	Drug: gadobutrol	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gadobutrol Gadobutrol in Healthy volunteers	Drug: gadobutrol Gadobutrol administration in healthy volunteers

Arm

Intervention/Treatment

Experimental: Gadobutrol

Gadobutrol in Healthy volunteers

Drug: gadobutrol

Gadobutrol administration in healthy volunteers

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts 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.