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Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers

Not Applicable
Completed
Conditions
Myocardial Infarction
Interventions
Other: MRI at D7
Biological: Blood samples
Registration Number
NCT02823886
Lead Sponsor
Hospices Civils de Lyon
Brief 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. 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
STEMI patientsMRI at D7-
STEMI patientsBlood samples-
Primary Outcome Measures
NameTimeMethod
Relationship between interleukin-1beta serum level and infarct sizeDay 7

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

Relationship between interleukin 6 serum level and infarct sizeDay 7

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

Relationship between interleukin 17 serum level and infarct sizeDay 7

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

Relationship between TNF-alpha serum level and infarct sizeDay 7

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

Relationship between polymorphonuclear neutrophil serum level and infarct sizeDay 7

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

Relationship between ST2 serum level and infarct sizeDay 7

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

Relationship between CRP serum level and infarct sizeDay 7

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

Secondary Outcome Measures
NameTimeMethod
relationship between the H24 peak values of serum level for TNF-alpha and functional and anatomical parametersarea 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.

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

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

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

relationship between the H24 peak values of serum level for interleukin 1 beta and the cardiovascular eventsarea 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
relationship between the H24 peak values of serum level for interleukin 17 and the cardiovascular eventsarea 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
relationship between the H24 peak values of serum level for polymorphonuclear neutrophil and functional and anatomical parametersarea 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.

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

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

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

relationship between the H24 peak values of serum level for ST2 and the cardiovascular eventsarea 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
relationship between the H24 peak values of serum level for polynuclear neutrophil and the cardiovascular eventsarea 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
relationship between the H24 peak values of serum level for interleukin-1beta and functional and anatomical parametersarea 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.

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

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

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

relationship between the H24 peak values of serum level for interleukin 6 and the cardiovascular eventsarea 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
relationship between the H24 peak values of serum level for TNF-alpha and the cardiovascular eventsarea 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
relationship between the H24 peak values of serum level for CRP and the cardiovascular eventsarea 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
relationship between the H24 peak values of serum level for interleukin 17 and functional and anatomical parametersarea 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.

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

Trial Locations

Locations (1)

Hospices Civils de Lyon

🇫🇷

Bron, France

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