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

C

Central Hospital, Nancy, France

Status

Terminated

Conditions

Heart Diseases

Treatments

Device: MRI compatible ElectroCardioGraph

Study type

Interventional

Funder types

Other

Identifiers

NCT02562534
2012-A01406-37

Details and patient eligibility

About

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

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 3 patient groups

Patients with conductive troubles
Other group
Description:
Patients with conductive troubles
Treatment:
Device: MRI compatible ElectroCardioGraph
Patients with rhythm troubles
Other group
Description:
Patients with rhythm troubles
Treatment:
Device: MRI compatible ElectroCardioGraph
Volunteers
Other group
Description:
Volunteers with normal ECG
Treatment:
Device: MRI compatible ElectroCardioGraph

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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