Status:
COMPLETED
Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Left Atrial Fibrosis
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
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-...
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 ...
Eligibility Criteria
Inclusion
- Healthy volunteers capable of being subjected to the prespecified tests of the study.
- Healthy volunteers that sign the informed consent after being informed.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02274246
Start Date
November 1 2014
End Date
March 1 2015
Last Update
August 19 2015
Active Locations (1)
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1
Hospital Clinic of Barcelona
Barcelona, Barcelona, Spain, 08036