Study Stopped
There was sufficient data to verify the primary endpoint
Creation of an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease.
DB-ECG-3T
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.
1 other identifier
interventional
19
1 country
1
Brief Summary
The aim is to create a database including recordings of ECG data recorded in an MRI acquisition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2014
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2016
CompletedJuly 2, 2021
June 1, 2021
2.3 years
September 28, 2015
June 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Patients with conductive troubles
OTHERPatients with conductive troubles
Patients with rhythm troubles
OTHERPatients with rhythm troubles
Volunteers
OTHERVolunteers with normal ECG
Interventions
MRI with ECG control for people with healthy heart or heart diseases
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire de Nancy
Nancy, 54000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian De Chillou, Pr
Central Hospital, Nancy, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist specialised in rhythmology
Study Record Dates
First Submitted
September 28, 2015
First Posted
September 29, 2015
Study Start
January 7, 2014
Primary Completion
April 8, 2016
Study Completion
April 8, 2016
Last Updated
July 2, 2021
Record last verified: 2021-06