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Completed

NCT Number: NCT02274246

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

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.

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Key information

Conditions

Left Atrial Fibrosis Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gadobutrol

Drug

Gadobutrol administration in healthy volunteers

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.

    Time frame: Baseline

Secondary outcomes

  1. Adverse events

    Time frame: 1 week after intervention

  2. Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index.

    Time frame: 1 week after intervention

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study 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

Acronym: RESTORE-HV

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2014
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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