Heart DiseasesDB-ECG-3TNCT02562534
Creation of an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease.
A study testing MRI compatible ElectroCardioGraph in people with Heart Diseases, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim is to create a database including recordings of ECG data recorded in an MRI acquisition Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- MRI compatible ElectroCardioGraph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2014to 8 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 9Show fewer
- "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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
The aim is to create a database including recordings of ECG data recorded in an MRI acquisition
Read the 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.
- Conditions
- Heart Diseases
- Being tested
- MRI compatible ElectroCardioGraph
- Keywords
- ECG, MRI, rhythm troubles, conductive troubles, ECG artifacts, Database
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI compatible ElectroCardioGraphDevice
MRI with ECG control for people with healthy heart or heart diseases
| Study group | Role | What they receive |
|---|---|---|
| Patients with conductive troubles | Other | Patients with conductive troubles Receives: Device: MRI compatible ElectroCardioGraph |
| Patients with rhythm troubles | Other | Patients with rhythm troubles Receives: Device: MRI compatible ElectroCardioGraph |
| Volunteers | Other | Volunteers with normal ECG Receives: Device: MRI compatible ElectroCardioGraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start7 Jan 2014
- Primary completion8 Apr 2016
- Study completion8 Apr 2016
Why it stopped: There was sufficient data to verify the primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jean-Marc SELLAL, Central Hospital, Nancy, France
- Investigators
- Christian De Chillou, Pr, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562534
- Sponsor's protocol ID
- 2012-A01406-37
- Acronym
- DB-ECG-3T
- Status last verified
- Jun 2021
- First submitted
- 28 Sep 2015
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02562534
- Acronym / sponsor ID
- DB-ECG-3T / 2012-A01406-37
- Conditions
- Heart Diseases
- Keywords
- ECG, MRI, rhythm troubles, conductive troubles, ECG artifacts, Database
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was sufficient data to verify the primary endpoint
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 7 Jan 2014 (actual)
- Primary completion
- 8 Apr 2016 (actual)
- Study completion
- 8 Apr 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to create a database including recordings of ECG data recorded in an MRI acquisition
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with conductive troubles | Other | Device: MRI compatible ElectroCardioGraphPatients with conductive troubles |
| Patients with rhythm troubles | Other | Device: MRI compatible ElectroCardioGraphPatients with rhythm troubles |
| Volunteers | Other | Device: MRI compatible ElectroCardioGraphVolunteers with normal ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For all subjects:
- For the groups :
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI compatible ElectroCardioGraphMRI with ECG control for people with healthy heart or heart diseases | Device | Patients with conductive troubles, Patients with rhythm troubles, Volunteers |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: There was sufficient data to verify the primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian De Chillou, Pr principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI compatible ElectroCardioGraph in people with Heart Diseases, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: There was sufficient data to verify the primary endpoint). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the ECG signal quality (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.