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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS.
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- 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.
Arms & Interventions
Gadobutrol
Gadobutrol in Healthy volunteers
Intervention: gadobutrol (Drug)
Outcomes
Primary Outcomes
Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS.
Time Frame: Baseline
Secondary Outcomes
- 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)
Investigators
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica