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

Left Atrial Fibrosis Clinical Trial

— RESTORE-HV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274246
• Other study ID #: RESTORE-HV
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2014
• Last updated: August 17, 2015
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fibrosis
• Left Atrial Fibrosis

Intervention

Drug:
• gadobutrol
Gadobutrol administration in healthy volunteers

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS.		Baseline	No
Secondary	Adverse events		1 week after intervention	No
Secondary	Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index.		1 week after intervention	No