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
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
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 19, 2015
August 1, 2015
4 months
October 20, 2014
August 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
Gadobutrol
EXPERIMENTALGadobutrol in Healthy volunteers
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers capable of being subjected to the prespecified tests of the study.
- Healthy volunteers that sign the informed consent after being informed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic of Barcelona
Barcelona, Barcelona, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Manager
Study Record Dates
First Submitted
October 20, 2014
First Posted
October 24, 2014
Study Start
November 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 19, 2015
Record last verified: 2015-08