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

Heart Diseases Clinical Trial

— DB-ECG-3T  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02562534
• Other study ID #: 2012-A01406-37
• Status: Terminated
• Phase: N/A
• Start date: January 7, 2014
• Est. completion date: April 8, 2016

Study information

• Verified date: June 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: April 8, 2016
• Est. primary completion date: April 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• MRI compatible ElectroCardioGraph
MRI with ECG control for people with healthy heart or heart diseases

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the ECG signal quality	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