Creation of an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease.

Not Applicable

Terminated

• Conditions: Heart Diseases
• Interventions: Device: MRI compatible ElectroCardioGraph

• Registration Number: NCT02562534
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The aim is to create a database including recordings of ECG data recorded in an MRI acquisition

Detailed Description

ECG monitoring is an essential tool during MRI, especially for cardiac MRI (CMR). Indeed, the system needs to synchronize the acquisitions on the cardiac cycles. To identify the cycle, the system is based on the ECG. Furthermore, patients having a CMR can be at risk of presenting cardiac rhythm troubles, and must be monitored with a trustable system.

The problem is that in MRI, a lot of artefacts occur, leading to dramatic disturbances of the signal. A lot of tools are used to try to remove the artefacts. The aim of this study is to create a database that can be used to test the different tools to remove the artefacts.

The investigators intend to include all types of ECG patterns that can exist, to allow to test the tools in all situations.

Study Timeline

• Study Start: 2014-01-07
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-29
• Primary Completion: 2016-04-08
• Study Completion: 2016-04-08
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• For all subjects:

  • To be more than 18
  • To be enroled in a social security plan
  • To have signed an informed consent
  • To have preliminary medical examination

• For the groups :

  • "normal ECG" group : sinus rhythm without conductive troubles. Normal pattern of the QRS
  • "conductive troubles group" : patients with typical right bundle branch block, or typical left bundle branch block pattern.
  • "rhythm trouble group" : patients with premature atrial beats or premature ventricular beats

Exclusion Criteria

• Contraindication: implantable devices (cardiac stimulators, defibrillators, cochlear implants, etc.), metallic foreign bodies
• Impossibility to undergo MRI: claustrophobia, morbid obesity.
• Pregnancy or risk of pregnancy.
• Patients under a measure of legal protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volunteers	MRI compatible ElectroCardioGraph	Volunteers with normal ECG
Patients with conductive troubles	MRI compatible ElectroCardioGraph	Patients with conductive troubles
Patients with rhythm troubles	MRI compatible ElectroCardioGraph	Patients with rhythm troubles

Primary Outcome Measures

Name	Time	Method
Evaluation of the ECG signal quality	One year	Evaluation of the ECG signal quality acquired in the MRI 3 Tesla by measuring the amplitude of the QRS complex (in millivolts). Conformity with IEC (International Electrotechnical Commission) 60601-2-51 standard.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nancy; 🇫🇷 Nancy, France