Back to resultsInflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers (RIFIFI)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI at D7
Blood samples
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Infarction focused on measuring myocardial infarction, MRI, inflammatory biomarkers
Eligibility Criteria
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
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STEMI patients
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
Secondary Outcome Measures
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
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
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
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
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
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
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
relationship between the H24 peak values of serum level for interleukin 1 beta and the cardiovascular events
relationship between the H24 peak values of serum level for interleukin 6 and the cardiovascular events
relationship between the H24 peak values of serum level for interleukin 17 and the cardiovascular events
relationship between the H24 peak values of serum level for TNF-alpha and the cardiovascular events
relationship between the H24 peak values of serum level for CRP and the cardiovascular events
relationship between the H24 peak values of serum level for ST2 and the cardiovascular events
relationship between the H24 peak values of serum level for polynuclear neutrophil and the cardiovascular events
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.
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.
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.
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.
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.
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..
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02823886
Brief Title
Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers
Acronym
RIFIFI
Official Title
Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers of Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 21, 2017 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, MRI, inflammatory biomarkers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STEMI patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MRI at D7
Intervention Description
The infarct size measured on MRI at 7 days.
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
Blood samples at H0; H4; H12; H24, H48, D7 and 1 month post MI
Primary Outcome Measure Information:
Title
Relationship between interleukin-1beta serum level and infarct size
Description
the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days
Time Frame
Day 7
Title
Relationship between interleukin 6 serum level and infarct size
Description
the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days
Time Frame
Day 7
Title
Relationship between interleukin 17 serum level and infarct size
Description
the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days
Time Frame
Day 7
Title
Relationship between TNF-alpha serum level and infarct size
Description
the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days
Time Frame
Day 7
Title
Relationship between CRP serum level and infarct size
Description
the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days
Time Frame
Day 7
Title
Relationship between ST2 serum level and infarct size
Description
the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days
Time Frame
Day 7
Title
Relationship between polymorphonuclear neutrophil serum level and infarct size
Description
the relationship between serum measured at H24 and the infarct size measured on MRI at 7 days
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Relationship between H24 peak or area under curve interleukin-1beta serum level and the size of no reflow
Description
concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI
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
Title
Relationship between H24 peak or area under curve interleukin 6 serum level and the size of no reflow
Description
concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI
Time Frame
Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
Title
Relationship between H24 peak or area under curve interleukin 17 serum level and the size of no reflow
Description
concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI
Time Frame
Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
Title
Relationship between H24 peak or area under curve TNF-alpha serum level and the size of no reflow
Description
and concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI
Time Frame
Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
Title
Relationship between H24 peak or area under curve CRP serum level and the size of no reflow
Description
and concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI
Time Frame
Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
Title
Relationship between H24 peak or area under curve polymorphonuclear neutrophil serum level and the size of no reflow
Description
and concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI
Time Frame
Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
Title
Relationship between H24 peak or area under curve ST2 serum level and the size of no reflow
Description
concerning the MRI, it is the measure of myocardial oedema, intracardiac hemorrhage and microvascular obstruction measured on MRI
Time Frame
Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
relationship between the H24 peak values of serum level for interleukin-1beta and functional and anatomical parameters
Description
relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.
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
Title
relationship between the H24 peak values of serum level for interleukin 6 and functional and anatomical parameters
Description
relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.
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
Title
relationship between the H24 peak values of serum level for interleukin 17 and functional and anatomical parameters
Description
relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.
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
Title
relationship between the H24 peak values of serum level for TNF-alpha and functional and anatomical parameters
Description
relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.
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
Title
relationship between the H24 peak values of serum level for CRP and functional and anatomical parameters
Description
relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.
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
Title
relationship between the H24 peak values of serum level for ST2 and functional and anatomical parameters
Description
relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days..
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
Title
relationship between the H24 peak values of serum level for polymorphonuclear neutrophil and functional and anatomical parameters
Description
relationship between area under curve and functional and anatomical parameters (end-systolic volume and end -diastolic Volume) measured on MRI at 7 days.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
Learn more about this trial
Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers
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