Myocardial InfarctionInfarctusGSINCT02360150
Evaluation of Myocardial Viability : Dual Energy Cardiac CT vs. Cardiac MRI
A study testing second propeller arm scanner in people with Myocardial Infarction, run by University Hospital, Rouen at 1 site in France.
Trial summary
The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- second propeller arm scanner
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2015to 7 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman
- Major patient
- Patient with electrical, biological and clinical signs of myocardial infarction, with late presentation (>24 hours)
- Creatinine clearance (calculated using the Cockcroft (<age 65) or MDRD (> 65 years))formula > 30 ml / min.
- Affiliation to the french social security scheme.
- Women of childbearing age: Negative pregnancy test (urine test).
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- Postmenopausal women, menopause confirmation of diagnosis
- Patient able to understand the spoken and written French.
- Signature of informed consent
Who cannot join
- Collapsus or organ failure requiring urgent care in intensive care unit
- Arrhythmia and/or non-reducible tachycardia.
- History of allergic reaction after iodinated contrast medium injection.
- History of nephrogenic systemic fibrosis.
- History of claustrophobia
- Unbalanced asthma.
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- Acute pulmonary edema.
- Pregnant or breastfeeding women.
- Clinical signs of thyrotoxicosis.
- Person placed under judicial protection,
- Patient suffering from serious psychiatric disease.
- Patients participating in another clinical trial.
- Contraindication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.
The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.
This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.
Read the detailed description
Percutaneous coronary intervention is not recommended in stable patients with late presentation myocardial infarction, and myocardial viability needs to be evaluated before the procedure. The aim of the study is to evaluate the sensibility and specificity of dual-energy CT for the evaluation of myocardial viability in comparison to cardiac MRI.
The experimental procedure is limited to a second CT acquisition performed 10 minutes in dual energy mode.
Sensitivity and Specificity of delayed enhancement >50% of myocardial thickness provided by dual-energy CT will be evaluated in comparison to cardiac MRI.
- Conditions
- Myocardial Infarction
- Being tested
- second propeller arm scanner
- Keywords
- cardiac angiography, cardiac MRI
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second propeller arm scannerRadiation
The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement.
| Study group | Role | What they receive |
|---|---|---|
| second propeller arm scanner | Experimental | The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement to the inclusion visit. Receives: Radiation: second propeller arm scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT
To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.
Measured: Day 4
Secondary outcomes (1)
Number of patient with a possible evaluation of myocardial viability using cardiac MRI
To study the sensitivity of cardiac MRI for the evaluation of myocardial viability in patients with late presentation myocardial infarction.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start10 Jan 2015
- Primary completion7 Oct 2016
- Study completion7 Oct 2016
Why it stopped: Replacement of the General Electric Healthcare DISCOVERY 750 HD CT scanner (the project's experimental device) in the medical imaging department with a new CT scanner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin DUBOURG, Doctor, Principal investigator, University Hospital, RouenJean-Nicolas DACHER, Professor, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360150
- Sponsor's protocol ID
- 2013/205/HP
- Acronym
- InfarctusGSI
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2014
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.
- ClinicalTrials.gov ID
- NCT02360150
- Acronym / sponsor ID
- InfarctusGSI / 2013/205/HP
- Conditions
- Myocardial Infarction
- Keywords
- cardiac angiography, cardiac MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Replacement of the General Electric Healthcare DISCOVERY 750 HD CT scanner (the project's experimental device) in the medical imaging department with a new CT scanner
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 7 Oct 2016 (actual)
- First posted
- 10 Feb 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 purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.
This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.
Detailed description
Percutaneous coronary intervention is not recommended in stable patients with late presentation myocardial infarction, and myocardial viability needs to be evaluated before the procedure. The aim of the study is to evaluate the sensibility and specificity of dual-energy CT for the evaluation of myocardial viability in comparison to cardiac MRI.
The experimental procedure is limited to a second CT acquisition performed 10 minutes in dual energy mode.
Sensitivity and Specificity of delayed enhancement >50% of myocardial thickness provided by dual-energy CT will be evaluated in comparison to cardiac MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| second propeller arm scanner | Experimental | Radiation: second propeller arm scannerThe experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement to the inclusion visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Man or woman
- Major patient
- Patient with electrical, biological and clinical signs of myocardial infarction, with late presentation (>24 hours)
- Creatinine clearance (calculated using the Cockcroft (<age 65) or MDRD (> 65 years))formula > 30 ml / min.
- Affiliation to the french social security scheme.
Key exclusion criteria (13 listed)
- Collapsus or organ failure requiring urgent care in intensive care unit
- Arrhythmia and/or non-reducible tachycardia.
- History of allergic reaction after iodinated contrast medium injection.
- History of nephrogenic systemic fibrosis.
- History of claustrophobia
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 |
|---|---|---|
| second propeller arm scannerThe experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement. | Radiation | second propeller arm scanner |
Primary outcome
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT
Time frame: Day 4
To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.
1 secondary outcome
Number of patient with a possible evaluation of myocardial viability using cardiac MRI
Time frame: Day 4
Results and safety
The study was stopped early (reason given: Replacement of the General Electric Healthcare DISCOVERY 750 HD CT scanner (the project's experimental device) in the medical imaging department with a new CT scanner). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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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.
Benjamin DUBOURG, Doctor principal investigator
University Hospital, Rouen
Jean-Nicolas DACHER, Professor study director
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing second propeller arm scanner in people with Myocardial Infarction, run by University Hospital, Rouen 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 13 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 14 Apr 2026. 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: Replacement of the General Electric Healthcare DISCOVERY 750 HD CT scanner (the project's experimental device) in the medical imaging department with a new CT scanner). 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?
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT (time frame: Day 4). 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 14 Apr 2026.