The Role of Inflammation in Myocardial Infarction

NCT06065514 | Completed

• 1 other identifier: DD5025
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 4

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.

Conditions

Myocardial Infarction

Keywords

STEMI; NSTEMI; Inflammation; Unstable Angina; Cytokines; Adipokines; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of heart failure

  6-months

• Incidence of MACE

  6-months

• Change in cytokines and adipokines (pg/mL)

  6-months

• Change in the left ventricular end-diastolic volume index (percent)

  6-months

Other Outcomes (7)

• Change in IL-6

  30-days

• Change in IL-10

  30-days

• Change in IL-18

  30-days

Study Arms (2)

Patients Group

The study plans to include 120 consecutive patients above 18 years old presenting with STEMI, NSTEMI, or UA and referred for coronary angiography.

Control Group

60 patients will consist of the control group. The patient and control group will be matched at baseline by equating certain clinical characteristics of interest between the exposed and unexposed groups. 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute coronary syndromes (ST-ACS, NSTE-ACS, UA), who underwent coronary angiography.

You may qualify if:

• ACS (ST-ACS, NSTE-ACS, UA) referred for coronary angiography
• Above 18 years old
• Consent form obtained

You may not qualify if:

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

Sponsors & Collaborators

• Nicosia General Hospital: lead
• Aristotle University Of Thessaloniki: collaborator
• Hippocration General Hospital: collaborator

Study Sites (4)

Nicosia General Hospital

Nicosia, Nicosia, 2029, Cyprus

Location

1st University Department of Cardiology - AHEPA University Hospital

Thessaloniki, Greece, Greece

Location

2nd University Department of Cardiology

Thessaloniki, Greece, Greece

Location

3rd University Department of Cardiology

Thessaloniki, Greece, Greece

Location

Related 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.

  PMID: 35301174 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood sample

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Inflammation; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• George Kassimis, MD, PhD

  Second Department of Cardiology, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Stergios Tzikas, MD, PhD

  Third Department of Cardiology, Aristotle University of Thessaloniki

  STUDY DIRECTOR

• Antonios Ziakas, MD, PhD

  First Department of Cardiology, AHEPA University Hospital, Aristotle University of Thessaloniki

  STUDY DIRECTOR

• Andreas Mitsis, MD, MSc

  Nicosia General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 4, 2023
• Study Start: August 24, 2023
• Primary Completion: March 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2025-12

Locations

CY (1); GR (3)