Myocardial InfarctionMI-SCAR-MRINCT05967026
Characterization of Myocardial Infarction Scar Using Magnetic Resonance Imaging
An observational study of Myocardial Infarction, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The goal of this monocentric observationnal study is to describe the characteristics of the myocardial infarction scar in terms of transmurality in residual LVEF>35% patients. The primary objective is to determine the frequency of the criterion "intramural scar ≥1.47cm2" (measured by MRI) in patients who presented… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2023to Aug 2023
- Phase
- Observational
- 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
Study population: Patient with a history of acute coronary syndrome prior to inclusion and having undergone cardiac MRI and LVEF >35% measured at least 6 weeks post-IDM by echocardiography or MRI
Who may be able to join
- Age ≥ 18 years ;
- History of acute coronary syndrome prior to inclusion and having undergone cardiac MRI;
- LVEF >35% measured at least 6 weeks post-IDM by echocardiography or MRI;
Who cannot join
- Patient with an implantable cardiac device (implantable cardioverter defibrillator or pacemaker) prior to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this monocentric observationnal study is to describe the characteristics of the myocardial infarction scar in terms of transmurality in residual LVEF>35% patients.
The primary objective is to determine the frequency of the criterion "intramural scar ≥1.47cm2" (measured by MRI) in patients who presented with myocardial infarction with residual LVEF≥35%.
- Conditions
- Myocardial Infarction
- Keywords
- cardiac magnetic resonance, sudden cardiac death, risk stratification
- Medical subject headings
- Myocardial Infarction, Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramural scar surface in cm²
Intramural scar surface in cm²>1.47cm²
Measured: 6 weeks after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAMMACHE Nefissa, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967026
- Sponsor's protocol ID
- 2023PI071
- Acronym
- MI-SCAR-MRI
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Myocardial Infarction Scar Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05967026
- Acronym / sponsor ID
- MI-SCAR-MRI / 2023PI071
- Conditions
- Myocardial Infarction
- Keywords
- cardiac magnetic resonance, sudden cardiac death, risk stratification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 1 Aug 2023 (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.
The goal of this monocentric observationnal study is to describe the characteristics of the myocardial infarction scar in terms of transmurality in residual LVEF>35% patients.
The primary objective is to determine the frequency of the criterion "intramural scar ≥1.47cm2" (measured by MRI) in patients who presented with myocardial infarction with residual LVEF≥35%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a history of acute coronary syndrome prior to inclusion and having undergone cardiac MRI and LVEF >35% measured at least 6 weeks post-IDM by echocardiography or MRI
Key inclusion criteria (3 listed)
- Age ≥ 18 years ;
- History of acute coronary syndrome prior to inclusion and having undergone cardiac MRI;
- LVEF >35% measured at least 6 weeks post-IDM by echocardiography or MRI;
Key exclusion criteria (1 listed)
- Patient with an implantable cardiac device (implantable cardioverter defibrillator or pacemaker) prior to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intramural scar surface in cm²
Time frame: 6 weeks after myocardial infarction
Intramural scar surface in cm²>1.47cm²
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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?
An observational study of Myocardial Infarction, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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?
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?
Intramural scar surface in cm² (time frame: 6 weeks after myocardial infarction). 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 1 Aug 2023.