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Myocardial InfarctionRIFIFINCT02823886

Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers

A study testing MRI at D7 and Blood samples in people with Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An intense inflammatory reaction is triggered by the ischemic injury during myocardial infarction. The inflammatory processes involved are complex and haven't been explored in detail in human patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myocardial Infarction
What is being tested?
MRI at D7 and Blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteFrance
Study dates
21 Jan 2017to 10 Jul 2017
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients, aged over 18, without any legal protection measure,
  • Having a health coverage,
  • Presenting within 12 hours of the onset of chest pain,
  • Who have ST segment elevation ≥0.2 millivolt (mV) in two contiguous leads,
  • For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
  • he culprit coronary artery has to be the left anterior descending (LAD) or the right coronary (RC)
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  • The LAD or RC artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
  • Preliminary oral informed consent followed by signed informed consent as soon as possible
  • Final TIMI ≥ 2

Who cannot join

  • Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
  • Patients with cardiogenic shock
  • Patient in Cardiac arrest
  • History of Myocardial Infarction
  • Contre-indication to MRI : claustrophobia, pacemaker or cardiac defibrillator , eye metal body allergy to gadolinium
  • Patient with Atrial Fibrillation.
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  • Patients with loss of consciousness or (Glasgow <14)
  • known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
  • Patients with any disorder associated with immunological dysfunction
  • Adult with legal protection measure

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hospices Civils de Lyon

    Bron, 69500

Other trials in France

About this study

Official title: Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers of Inflammation

An intense inflammatory reaction is triggered by the ischemic injury during myocardial infarction. The inflammatory processes involved are complex and haven't been explored in detail in human patients. This inflammatory response can increase myocardial damage following reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac death).

Cardiac MRI can assess the size of myocardial infarction and many other parameters associated with myocardial injury: edema, hemorrhage, micro-vascular obstruction.

Read more

(However the association between biomarkers of inflammation and these imaging parameters is not known).

There is very little data correlating imaging markers of myocardial injury to the biokinetics of inflammation biomarkers.

In this study, the aim is to assess the relationship between the kinetics of specific inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2), neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20 acute mycardial infarction (AMI) patients.

Being tested
MRI at D7, Blood samples
Keywords
myocardial infarction, MRI, inflammatory biomarkers
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI at D7Other

    The infarct size measured on MRI at 7 days.

  • Blood samplesBiological

    Blood samples at H0; H4; H12; H24, H48, D7 and 1 month post MI

Study groups in NCT02823886
Study groupRoleWhat they receive
STEMI patientsExperimentalNot described
Receives: Other: MRI at D7; Biological: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relationship between interleukin-1beta serum level and infarct size

    the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days

    Measured: Day 7

  2. Relationship between interleukin 6 serum level and infarct size

    the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days

    Measured: Day 7

  3. Relationship between interleukin 17 serum level and infarct size

    the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days

    Measured: Day 7

  4. Relationship between TNF-alpha serum level and infarct size

    the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days

    Measured: Day 7

  5. Relationship between CRP serum level and infarct size

    the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days

    Measured: Day 7

  6. Relationship between ST2 serum level and infarct size

    the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days

    Measured: Day 7

  7. Relationship between polymorphonuclear neutrophil serum level and infarct size

    the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days

    Measured: Day 7

Secondary outcomes (21)
  1. Relationship between H24 peak or area under curve interleukin-1beta serum level and the size of no reflow

    concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI

    Measured: Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI

  2. Relationship between H24 peak or area under curve interleukin 6 serum level and the size of no reflow

    concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI

    Measured: Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI

  3. Relationship between H24 peak or area under curve interleukin 17 serum level and the size of no reflow

    concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI

    Measured: Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI

  4. Relationship between H24 peak or area under curve TNF-alpha serum level and the size of no reflow

    and concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI

    Measured: Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI

  5. Relationship between H24 peak or area under curve CRP serum level and the size of no reflow

    and concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI

    Measured: Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI

  6. Relationship between H24 peak or area under curve polymorphonuclear neutrophil serum level and the size of no reflow

    and concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI

    Measured: Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI

  7. Relationship between H24 peak or area under curve ST2 serum level and the size of no reflow

    concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI

    Measured: Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI

  8. relationship between the H24 peak values of serum level for interleukin 1 beta and the cardiovascular events

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day7 and 1 month post MI) for biomarkers and follow up at 1 month

  9. relationship between the H24 peak values of serum level for interleukin 6 and the cardiovascular events

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day7 and 1 month post MI) for biomarkers and follow up at 1 month

  10. relationship between the H24 peak values of serum level for interleukin 17 and the cardiovascular events

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day7 and 1 month post MI) for biomarkers and follow up at 1 month

  11. relationship between the H24 peak values of serum level for TNF-alpha and the cardiovascular events

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day7 and 1 month post MI) for biomarkers and follow up at 1 month

  12. relationship between the H24 peak values of serum level for CRP and the cardiovascular events

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day7 and 1 month post MI) for biomarkers and follow up at 1 month

  13. relationship between the H24 peak values of serum level for ST2 and the cardiovascular events

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day7 and 1 month post MI) for biomarkers and follow up at 1 month

  14. relationship between the H24 peak values of serum level for polynuclear neutrophil and the cardiovascular events

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day7 and 1 month post MI) for biomarkers and follow up at 1 month

  15. relationship between the H24 peak values of serum level for interleukin-1beta and functional and anatomical parameters

    relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI) for biomarkers and D7 for the MRI

  16. relationship between the H24 peak values of serum level for interleukin 6 and functional and anatomical parameters

    relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI) for biomarkers and D7 for the MRI

  17. relationship between the H24 peak values of serum level for interleukin 17 and functional and anatomical parameters

    relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI) for biomarkers and D7 for the MRI

  18. relationship between the H24 peak values of serum level for TNF-alpha and functional and anatomical parameters

    relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI) for biomarkers and D7 for the MRI

  19. relationship between the H24 peak values of serum level for CRP and functional and anatomical parameters

    relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI) for biomarkers and D7 for the MRI

  20. relationship between the H24 peak values of serum level for ST2 and functional and anatomical parameters

    relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days..

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI) for biomarkers and D7 for the MRI

  21. relationship between the H24 peak values of serum level for polymorphonuclear neutrophil and functional and anatomical parameters

    relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.

    Measured: area under curve (pharmacokinetic : Hour 0; Hour 4; Hour 12; Hour 24, Hour 48, Day 7 and 1 month post MI) for biomarkers and D7 for the MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study start21 Jan 2017
  3. Primary completion10 Jul 2017
  4. Study completion10 Jul 2017

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823886
Sponsor's protocol ID
69HCL16_0130
Acronym
RIFIFI
Status last verified
Sep 2025
First submitted
28 Jun 2016
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • This study confirms the strong association between infarct size and CRP levels, but does not demonstrate any significant relationship with the other biomarkers investigated (IL-6, IL-8, and IL-10). Among the three markers of myocardial injury assessed, myocardial hemorrhage appears to be strongly associated with the release of inflammatory biomarkers following reperfused STEMI. Attenuation of reperfusion-induced hemorrhage may therefore represent a novel therapeutic target for future adjunctive treatments in STEMI patients. Additional cytokine measurements are currently being performed to further refine the assessment of the relationship between hemorrhage, infarct size, and other inflammatory biomarkers.

Questions about this trial

What is this clinical trial studying?

A study testing MRI at D7 and Blood samples in people with Myocardial Infarction, run by Hospices Civils de Lyon 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 10 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 11 Sep 2025. 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?

Relationship between interleukin-1beta serum level and infarct size (time frame: Day 7). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823886, which also lists 1 linked publication.

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 11 Sep 2025.

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