The Role of Inflammation in Myocardial Infarction

Recruiting

• Conditions: Myocardial Infarction

• Registration Number: NCT06065514
• Lead Sponsor: Nicosia General Hospital

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.

Study Timeline

• Study Start: 2023-08-24
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-03-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Mortality	6-months	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)

Secondary Outcome Measures

Name	Time	Method
Incidence of heart failure	6-months	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.
Incidence of MACE	6-months	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).
Change in cytokines and adipokines (pg/mL)	6-months	The comparison between the values of the studied biomarkers at the four-time intervals (H0, H6-12, H24-48, D30).
Change in the left ventricular end-diastolic volume index (percent)	6-months	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

Trial Locations

Locations (4)

Nicosia General Hospital; 🇨🇾 Nicosia, Cyprus

1st University Department of Cardiology - AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece

2nd University Department of Cardiology; 🇬🇷 Thessaloniki, Greece

3rd University Department of Cardiology; 🇬🇷 Thessaloniki, Greece