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

• Register: ClinicalTrials.gov
• Last refreshed on: 31 August 2015
• Main ID: NCT02274246
• Date of registration: 20/10/2014
• Prospective Registration: Yes
• Primary sponsor: Fundacion Clinic per a la Recerca Biomédica
• Public title: Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV) RESTORE-HV
• Scientific 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
• Date of first enrolment: November 2014
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02274246
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 1

Countries of recruitment

Spain

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Left Atrial Fibrosis

Intervention(s)

Drug: gadobutrol

Primary Outcome(s)

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 Outcome(s)

Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index. [Time Frame: 1 week after intervention]

Adverse events [Time Frame: 1 week after intervention]

Secondary ID(s)

RESTORE-HV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors