Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers
RIFIFI
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedStudy Start
First participant enrolled
January 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2017
CompletedSeptember 11, 2025
September 1, 2025
6 months
June 28, 2016
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (21)
Relationship between H24 peak or area under curve interleukin-1beta serum level and the size of no reflow
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
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
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
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
Hour 24, Hour 48, Day 7 and 1 month post MI for biomarkers and Day 7 for the MRI
- +16 more secondary outcomes
Study Arms (1)
STEMI patients
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Bron, 69500, France
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
July 6, 2016
Study Start
January 21, 2017
Primary Completion
July 10, 2017
Study Completion
July 10, 2017
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share