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

June 29, 2021 updated by: Dr Jean-Marc SELLAL, Central Hospital, Nancy, France

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.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Centre Hospitalier Universitaire de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with conductive troubles
Device: MRI compatible ElectroCardioGraph
MRI with ECG control for people with healthy heart or heart diseases
Other: Patients with rhythm troubles
Device: MRI compatible ElectroCardioGraph
MRI with ECG control for people with healthy heart or heart diseases
Other: Volunteers
Volunteers with normal ECG
Device: MRI compatible ElectroCardioGraph
MRI with ECG control for people with healthy heart or heart diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the ECG signal quality
Time Frame: 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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Christian De Chillou, Pr, Chu de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2014

Primary Completion (Actual)

April 8, 2016

Study Completion (Actual)

April 8, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01406-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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