NCT03031587: VAIMTH-IRM

Validation of Thermometric Cardiac Imaging by MRI

Completed NA Last updated 10 February 2022

What this trial tests

NA trial testing Additional MRI acquisition sequences in Cardiac MRI in 61 participants. Completed in 13 June 2019.

Timeline

24 May 2017

Primary endpoint
13 June 2019

13 June 2019

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	61
Start date	24 May 2017
Primary completion	13 June 2019
Estimated completion	13 June 2019
Sites	1 location across France

Drugs / interventions tested

• Additional MRI acquisition sequences
• MRI — full drug profile →

Conditions studied

• Cardiac MRI — all drugs for Cardiac MRI →

Sponsor

University Hospital, Bordeaux

Who can join

15 and older, any sex, with Cardiac MRI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.