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

NCT ID: NCT02562534

Last Updated: 2021-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-07

Study Completion Date

2016-04-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with conductive troubles

Patients with conductive troubles

Group Type OTHER

MRI compatible ElectroCardioGraph

Intervention Type DEVICE

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

Patients with rhythm troubles

Patients with rhythm troubles

Group Type OTHER

MRI compatible ElectroCardioGraph

Intervention Type DEVICE

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

Volunteers

Volunteers with normal ECG

Group Type OTHER

MRI compatible ElectroCardioGraph

Intervention Type DEVICE

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

Interventions

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MRI compatible ElectroCardioGraph

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Dr Jean-Marc SELLAL

Cardiologist specialised in rhythmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian De Chillou, Pr

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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Centre Hospitalier Universitaire de Nancy

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01406-37

Identifier Type: -

Identifier Source: org_study_id

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