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Completed

NCT Number: NCT02823886

Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers

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.

(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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

MRI at D7

Other

The infarct size measured on MRI at 7 days.

blood samples

Biological

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

Primary outcomes

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

    Time frame: Day 7

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

  2. Relationship between interleukin 6 serum level and infarct size

    Time frame: Day 7

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

  3. Relationship between interleukin 17 serum level and infarct size

    Time frame: Day 7

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

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

    Time frame: Day 7

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

  5. Relationship between CRP serum level and infarct size

    Time frame: Day 7

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

  6. Relationship between ST2 serum level and infarct size

    Time frame: Day 7

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

  7. Relationship between polymorphonuclear neutrophil serum level and infarct size

    Time frame: Day 7

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

Secondary outcomes

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

    Time frame: 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: RIFIFI

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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