Clinical trial NCT06065514: The Role of Inflammation in Myocardial Infarction
Official title: The Complex Role of the Inflammation Response Following an Acute Myocardial Infarction: the INFINITY (INFlammatIoN amI sTudY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Keywords: STEMI
NSTEMI
Inflammation
Unstable Angina
Cytokines
Adipokines
Prognosis
Lead sponsor: Nicosia General Hospital
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
name: Hippocration General Hospital
First posted: 2023-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndromes (ST-ACS, NSTE-ACS, UA), who underwent coronary angiography.

Brief summary: The aim of this research is to study the prognostic role of a selected combination of cytokines and adipokines in patients with myocardial infarction, as well as to determine their role in the development of adverse cardiac remodeling.

Detailed description: After an acute myocardial infarction (AMI) the inflammatory response seems to have a central role and is connected to major adverse outcomes such as ischemia-reperfusion injury, adverse cardiac remodeling, infarct size, and poor prognosis. The concept of monitoring inflammatory markers as predictors of post-myocardial prognosis is gaining more momentum. Finding the appropriate inflammatory biomarker that would serve as a prognostic marker after an AMI and could stratify the risk for adverse outcomes, could be extremely useful.

INFINITY is a multi-center, prospective, observational cohort study, aiming to assess the complex role of inflammation in the post-AMI period. The study plans to include 120 consecutive patients above 18 years old admitted to the four centers participating in the study.

A panel of inflammatory cytokines and adipokines will be recorded. A venous blood sample will be collected on patient admission (H0), 6-12 hours after admission (H6-12), 24-48 hours after admission (H24-48), and at the 30-day visit (D30). Blood will be collected for routine laboratory tests, as well as to measure the levels of the cytokines IL-6, IL-10, IL-18, IL-17, and the adipokines leptin, apelin, and chemerin.

60 carefully selected patients will consist of the control group. The control group will consist of individuals to whom the obstructive coronary artery disease would be ruled out either by invasive or non-invasive coronary angiography or by myocardium perfusion SPECT or stress echocardiography. The patient and control group will be matched at baseline by equating certain clinical characteristics of interest between the exposed and unexposed groups.

The study will test the hypothesis that circulating plasma levels of the above inflammatory biomarkers reflect different clinical manifestations of coronary artery disease and correlate with coronary anatomy, the severity of coronary artery disease, and the prognosis in a 6-month follow-up period. Finally, will investigate whether the integration of the above inflammatory biomarkers into the already established prognostic risk stratification model, GRACE score, could further improve its predictive power.

Eligibility criteria: Inclusion Criteria:

1. ACS (ST-ACS, NSTE-ACS, UA) referred for coronary angiography
2. Above 18 years old
3. Consent form obtained

Exclusion Criteria:

1. Chronic Renal Failure (CRF) stage IV (e GFR \< 29 ml/min or creatinine \> 2 mg/dl)
2. Chronic Liver Disease (CLD) (ALT \> 2 times upper normal limit)
3. Chronic Inflammation and/or autoimmune diseases
4. Active Ca
5. Recent CVA (less than 1 month)
6. Recent (within 2 weeks) use of glucocorticoid drugs or immunosuppressive agents
7. Acute or chronic infection, major surgery, or trauma in the last month
8. Previous heart transplantation
9. Poor life expectancy
10. Cardiogenic shock
11. Cardiac arrest

Primary outcomes:
measure: Incidence of Mortality
timeFrame: 6-months
Secondary outcomes:
measure: Incidence of heart failure
timeFrame: 6-months
measure: Incidence of MACE
timeFrame: 6-months
measure: Change in cytokines and adipokines (pg/mL)
timeFrame: 6-months
measure: Change in the left ventricular end-diastolic volume index (percent)
timeFrame: 6-months
Other outcomes:
measure: Change in IL-6
timeFrame: 30-days
measure: Change in IL-10
timeFrame: 30-days
measure: Change in IL-18
timeFrame: 30-days
measure: Change in IL-17
timeFrame: 30-days
measure: Change in Leptin
timeFrame: 30-days
measure: Change in Apelin
timeFrame: 30-days
measure: Change in Chemerin
timeFrame: 30-days
Locations:
city: Nicosia
country: Cyprus
facility: Nicosia General Hospital
city: Thessaloniki
country: Greece
facility: 1st University Department of Cardiology - AHEPA University Hospital
city: Thessaloniki
country: Greece
facility: 2nd University Department of Cardiology
city: Thessaloniki
country: Greece
facility: 3rd University Department of Cardiology
Study officials:
affiliation: Second Department of Cardiology, Aristotle University of Thessaloniki
name: George Kassimis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Third Department of Cardiology, Aristotle University of Thessaloniki
name: Stergios Tzikas, MD, PhD
role: STUDY_DIRECTOR
affiliation: First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki
name: Antonios Ziakas, MD, PhD
role: STUDY_DIRECTOR
affiliation: Nicosia General Hospital
name: Andreas Mitsis, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Mitsis A, Kadoglou NPE, Lambadiari V, Alexiou S, Theodoropoulos KC, Avraamides P, Kassimis G. Prognostic role of inflammatory cytokines and novel adipokines in acute myocardial infarction: An updated and comprehensive review. Cytokine. 2022 May;153:155848. doi: 10.1016/j.cyto.2022.155848. Epub 2022 Mar 14.