Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers

NCT ID: NCT02823886

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-21
• Study Completion Date: 2017-07-10

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

STEMI patients

Group Type: EXPERIMENTAL

MRI at D7

Intervention Type: OTHER

The infarct size measured on MRI at 7 days.

Blood samples

Intervention Type: BIOLOGICAL

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

Interventions

MRI at D7

The infarct size measured on MRI at 7 days.

Intervention Type: OTHER

Blood samples

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon

Bron, , France

Countries

France

References

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.

Reference Type: BACKGROUND

Other Identifiers

69HCL16_0130

Identifier Type: -

Identifier Source: org_study_id