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

Use of a New ElectroCardioGraph to Create an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease in Order to Let go of Artifacts.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02562534

Acronym

DB-ECG-3T

Enrollment

Registered

2015-09-29

Start date

2014-01-07

Completion date

2016-04-08

Last updated

2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

ECG, MRI, rhythm troubles, conductive troubles, ECG artifacts, Database

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.

Interventions

DEVICEMRI compatible ElectroCardioGraph

MRI with ECG control for people with healthy heart or heart diseases

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026