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

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ClinicalTrials.gov Identifier: NCT02562534
Recruitment Status : Unknown
Verified September 2015 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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

Condition or disease Intervention/treatment Phase
Heart Diseases Device: MRI compatible ElectroCardioGraph Not Applicable

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 identifiy 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 occure, 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.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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.
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Patients with conductives troubles
Patients with conductives troubles
Device: MRI compatible ElectroCardioGraph
MRI with ECG control for personnes with healthy heart or heart diseases

Patients with rythm troubles
Patients with rythm troubles
Device: MRI compatible ElectroCardioGraph
MRI with ECG control for personnes with healthy heart or heart diseases

Volonteers
Volonteers with normal ECG
Device: MRI compatible ElectroCardioGraph
MRI with ECG control for personnes with healthy heart or heart diseases




Primary Outcome Measures :
  1. Evaluation of the ECG signal quality [ Time Frame: One year ]
    Evaluation of the ECG signal quality acquired in the MRI 3Tesla by measuring the amplitude of the QRS complex (in millivolts). Conformity with IEC 60601-2-51 standard.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, defibrilators, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562534


Contacts
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Contact: Jean-Marc Sellal, Dr +33 3 83 15 73 53 jeanmarc.sellal@free.fr
Contact: Claire Dessale +33 3 83 15 35 09 c.large@chu-nancy.fr

Locations
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France
Centre Hospitalier Universitaire de Nancy Recruiting
Nancy, France, 54000
Contact: Jean-Marc SELLAL, Dr    +33 3 83 15 73 53    jeanmarc.sellal@free.fr   
Contact: Claire DESSALE    +33 3 83 15 35 09    c.large@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Christian De Chillou, Pr CHU de Nancy

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02562534     History of Changes
Other Study ID Numbers: 2012-A01406-37
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Central Hospital, Nancy, France:
ECG
MRI
rythm troubles
conductive troubles
ECG artifacts
Database

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases