Validation of Thermometric Cardiac Imaging by MRI

NCT03031587 | Completed

• 1 other identifier: CHUBX 2016/15
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias resistant to medication. However, the absence of assessment of injury creation during radiofrequency application is an important issue. One of the objectives of the Institut Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time visualization of tissue temperature in all the myocardium with sufficient spatial and temporal resolution to characterize the induced thermal lesion. Today, investigators have developed and validated a new method for cardiac thermometry, associating rapid MRI acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium, largely sufficient to characterize a thermal treatment induced by radiofrequency where typical temperature rises of 40°C are observed during ablation. Temporal evolution of the temperature in each pixel provides access to calculation of the accumulated thermal dose that is a relevant indicator of the induced necrosis. This imaging method must now be evaluated in humans in order to test its robustness under real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize acquisition parameters and image processing. The aim of this research is thus to obtain specific MRI sequence of images of patients, on which will be evaluated the different algorithms of reconstruction and processing for temperature imaging. This study is a mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under MRI.

Conditions

Cardiac MRI

Keywords

Thermometric MRI; Myocardium

Outcome Measures

Primary Outcomes (1)

• Calculation of the temperature variance of various measurements realized in a region of interest of the myocardium

  1 measurement of temperature (°C) by cardiac beating

  Day 0

Study Arms (1)

MRI examination

EXPERIMENTAL

Each patient coming to the hospital for cardiac MRI examination can participate to the study if he/she meets the eligibility criteria

Other: Additional MRI acquisition sequences; Device: MRI

Interventions

Additional MRI acquisition sequences OTHER

It deals with specific sequences of rapid imaging acquisition in gradient echo (4 to 5 slices/cardiac cycle) with synchronization on the surface ECG systematically included in a cardiac MRI examination, together with update of the slice position depending on the respiratory state (established technique of navigator echo). The acquisition is repeated over 300 cardiac cycles to monitor myocardial temperature changes

MRI examination

MRI DEVICE

cardiac MRI

MRI examination

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requiring, as part of his/her traditional management of an MRI imaging examination
• Adults (age greater than or equal to 18 years) of both sexes
• Minors (aged 15 to 18) of both sexes subject to the parental agreement or its legal representative
• Patient's oral agreement after reading the information note
• Patient affiliate or beneficiary of a social security scheme.

You may not qualify if:

• Patients under 15 years of age
• Patient unable to give oral consent
• Patient deprived of liberty by judicial or administrative decision
• Major protected by the law
• Patient who does not meet the eligibility criteria for an MRI examination with or without injection.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

Location

Study Officials

• Pierre JAÏS, MD PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: May 24, 2017
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: February 10, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)