Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers (RIFIFI)

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.

(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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: MRI at D7; Biological: Blood samples

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEMI patients	Other: MRI at D7; The infarct size measured on MRI at 7 days.; Biological: Blood samples; Blood samples at H0; H4; H12; H24, H48, D7 and 1 month post MI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 7
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	Day 7
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	Day 7
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	Day 7
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	Day 7
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	Day 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	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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	Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
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	Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
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	Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
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	Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
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	Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
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	Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
relationship between the H24 peak values of serum level for interleukin 1 beta and the cardiovascular events		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
relationship between the H24 peak values of serum level for interleukin 6 and the cardiovascular events		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
relationship between the H24 peak values of serum level for interleukin 17 and the cardiovascular events		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
relationship between the H24 peak values of serum level for TNF-alpha and the cardiovascular events		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
relationship between the H24 peak values of serum level for CRP and the cardiovascular events		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
relationship between the H24 peak values of serum level for ST2 and the cardiovascular events		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
relationship between the H24 peak values of serum level for polynuclear neutrophil and the cardiovascular events		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
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.	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 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.	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 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.	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 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.	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 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.	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 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..	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 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.	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2017
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: MRI; myocardial infarction; inflammatory biomarkers
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 69HCL16_0130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No