Heart TransplantationARTEMISNCT03234205
Measurements of Myocardial Relaxation Time by MRI During Respiration
A study testing MRI scan in people with Heart Transplantation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- MRI scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2011to 19 Dec 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To have had a heart transplant, whenever
- To have an MRI scan of heart with measurement of T2 relaxation time (whatever the reason for examination)
- Major
- To be aware and cooperative
- Affiliation to social security plan
- To have given written consent after having received oral and written, clear and intelligible information
Who cannot join
- All contraindications to MRI (implantable defibrillator, cochlear implant, neurosurgical clip, intraorbital or encephalic metallic foreign body, endoprosthesis installed since less than 4 weeks, osteosynthesis materials installed since less than 6 weeks…)
- Instable hemodynamic status, acute respiratory failure, uncertain general status or necessity of continuous monitoring incompatible with MRI examination
- Minors or being under juridical protection or absence of social security
- Refusal or impossibility of informed consent of patient
Trial locations and contacts
1 site in 1 country.
About this study
Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable.
This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts.
Read more
The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients.
The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.
- Conditions
- Heart Transplantation
- Being tested
- MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDevice
MRI standard protocol with addition of:
- a second clinical respiratory belt besides belt usually installed for clinical examination
- a second clinical electrocardiogram sensor besides sensor usually installed for clinical examination
- 12 sequences during free respiration are added lasting supplementary 15 minutes
- Use of cardiac antennae usually used for cardiac MRI scans
| Study group | Role | What they receive |
|---|---|---|
| MRI scan during free respiration | Experimental | Not described Receives: Device: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality assessed y senior radiologists
Measured: baseline
Movement correction in images assessed by senior radiologists
Measured: baseline
Secondary outcomes (1)
Quantitative measurement of myocardial transversal relaxation time in 6 segments of short median axe cross-section of left ventricle in standard and ARTEMIS images
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start31 Aug 2011
- Primary completion19 Dec 2012
- Study completion19 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234205
- Sponsor's protocol ID
- 2011-A00154-37
- Acronym
- ARTEMIS
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Myocardial Relaxation Time by MRI During Respiration
- ClinicalTrials.gov ID
- NCT03234205
- Acronym / sponsor ID
- ARTEMIS / 2011-A00154-37
- Conditions
- Heart Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 31 Aug 2011 (actual)
- Primary completion
- 19 Dec 2012 (actual)
- Study completion
- 19 Dec 2012 (actual)
- First posted
- 31 Jul 2017 (actual)
- 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.
Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable.
This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts.
The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients.
The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scan during free respiration | Experimental | Device: MRI scan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- To have had a heart transplant, whenever
- To have an MRI scan of heart with measurement of T2 relaxation time (whatever the reason for examination)
- Major
- To be aware and cooperative
- Affiliation to social security plan
Key exclusion criteria (4 listed)
- All contraindications to MRI (implantable defibrillator, cochlear implant, neurosurgical clip, intraorbital or encephalic metallic foreign body, endoprosthesis installed since less than 4 weeks, osteosynthesis materials installed since less than 6 weeks…)
- Instable hemodynamic status, acute respiratory failure, uncertain general status or necessity of continuous monitoring incompatible with MRI examination
- Minors or being under juridical protection or absence of social security
- Refusal or impossibility of informed consent of patient
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 scanMRI standard protocol with addition of: * a second clinical respiratory belt besides belt usually installed for clinical examination * a second clinical electrocardiogram sensor besides sensor usually installed for clinical examination * 12 sequences during free respiration are added lasting supplementary 15 minutes * Use of cardiac antennae usually used for cardiac MRI scans | Device | MRI scan during free respiration |
Primary outcome
Image quality assessed y senior radiologists
Time frame: baseline
Movement correction in images assessed by senior radiologists
Time frame: baseline
1 secondary outcome
Quantitative measurement of myocardial transversal relaxation time in 6 segments of short median axe cross-section of left ventricle in standard and ARTEMIS images
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 scan in people with Heart Transplantation, 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 6 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: finished, as of the sponsor's last update on 3 Aug 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Image quality assessed y senior radiologists (time frame: baseline). The study lists 2 primary outcomes in all. 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 3 Aug 2017.