Back to resultsValidation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV) (RESTORE-HV)
Primary Purpose
Left Atrial Fibrosis
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
gadobutrol
Sponsored by
About this trial
This is an interventional diagnostic trial for Left Atrial Fibrosis focused on measuring Segmentation, GIMIAS® program, Atrial fibrillation, Left atrial fibrosis, Healthy volunteers
Eligibility 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.
Sites / Locations
- Hospital Clinic of Barcelona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gadobutrol
Arm Description
Gadobutrol in Healthy volunteers
Outcomes
Primary Outcome Measures
Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS.
Secondary Outcome Measures
Adverse events
Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index.
Full Information
NCT ID
NCT02274246
First Posted
October 20, 2014
Last Updated
August 17, 2015
Sponsor
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT02274246
Brief Title
Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Atrial Fibrosis
Keywords
Segmentation, GIMIAS® program, Atrial fibrillation, Left atrial fibrosis, Healthy volunteers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadobutrol
Arm Type
Experimental
Arm Description
Gadobutrol in Healthy volunteers
Intervention Type
Drug
Intervention Name(s)
gadobutrol
Intervention Description
Gadobutrol administration in healthy volunteers
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Adverse events
Time Frame
1 week after intervention
Title
Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index.
Time Frame
1 week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)
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