The Role of Inflammation in Myocardial Infarction

Myocardial Infarction Clinical Trial

— INFINITY  

Official title:

The Complex Role of the Inflammation Response Following an Acute Myocardial Infarction: the INFINITY (INFlammatIoN amI sTudY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065514
• Other study ID #: DD5025
• Status: Recruiting
• Start date: August 24, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: October 2023
• Source: Nicosia General Hospital
• Contact: Andreas Mitsis, MD, MSc
• Phone: +35796705559
• Email: andymits7[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Inflammation
• Myocardial Infarction

Locations

Country	Name	City	State
Cyprus	Nicosia General Hospital	Nicosia
Greece	1st University Department of Cardiology - AHEPA University Hospital	Thessaloniki
Greece	2nd University Department of Cardiology	Thessaloniki
Greece	3rd University Department of Cardiology	Thessaloniki

Sponsors (3)

Lead Sponsor	Collaborator
Nicosia General Hospital	Aristotle University Of Thessaloniki, Hippocration General Hospital

Countries where clinical trial is conducted

Cyprus,  Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in IL-6	The comparison between the values of IL-6 at the four-time intervals (H0, H6-12, H24-48, D30).	30-days
Other	Change in IL-10	The comparison between the values of IL-10 at the four-time intervals (H0, H6-12, H24-48, D30).	30-days
Other	Change in IL-18	The comparison between the values of IL-18 at the four-time intervals (H0, H6-12, H24-48, D30).	30-days
Other	Change in IL-17	The relationship between the levels of IL-17 (peak H24-48 measurement and area under curve based on the pharmacokinetics of each biomarker based on H0, H6-12, H24-48, and D30 post-enrollment measurements) with all-cause 6-month mortality (cardiac and non-cardiac mortality).	30-days
Other	Change in Leptin	The comparison between the values of Leptin at the four-time intervals (H0, H6-12, H24-48, D30).	30-days
Other	Change in Apelin	The comparison between the values of Apelin at the four-time intervals (H0, H6-12, H24-48, D30).	30-days
Other	Change in Chemerin	The comparison between the values of Chemerin at the four-time intervals (H0, H6-12, H24-48, D30).	30-days
Primary	Incidence of Mortality	The relationship between the levels of each biomarker (peak H24-48 measurement and area under curve based on the pharmacokinetics of each biomarker based on H0, H6-12, H24-48, and D30 post-enrollment measurements) with all-cause 6-month mortality (cardiac and non-cardiac mortality)	6-months
Secondary	Incidence of heart failure	The relationship between the levels of each biomarker (peak measurement H24-48 and area under curve based on the pharmacokinetics of each biomarker based on measurements H0, H6-12, H24-48, and D30 post-enrollment) with the development of heart failure within a follow-up interval of 6 months after enrollment.	6-months
Secondary	Incidence of MACE	The relationship between the levels of each biomarker (peak measurement H24-48 and area under curve based on the pharmacokinetics of each biomarker based on measurements H0, H6-12, H24-48, and D30 post-enrollment) with 6-month MACEs (non-fatal MI, unplanned repeated revascularization, acute heart failure or angina/ACS requiring rehospitalization, sudden cardiac death).	6-months
Secondary	Change in cytokines and adipokines (pg/mL)	The comparison between the values of the studied biomarkers at the four-time intervals (H0, H6-12, H24-48, D30).	6-months
Secondary	Change in the left ventricular end-diastolic volume index (percent)	Change in the left ventricular end-diastolic volume index (percent) is assessed in patients with myocardial infarction at 6-months follow-up with intermediate assessments at day 7 after onset	6-months