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Completed

NCT Number: NCT06065514

The Role of Inflammation in Myocardial Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nicosia General Hospital, Nicosia, Cyprus

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Incidence of Mortality

    Time frame: 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 outcomes

  1. Incidence of heart failure

    Time frame: 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.

  2. Incidence of MACE

    Time frame: 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).

  3. Change in cytokines and adipokines (pg/mL)

    Time frame: 6-months

    The comparison between the values of the studied biomarkers at the four-time intervals (H0, H6-12, H24-48, D30).

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

    Time frame: 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

Other outcomes

  1. Change in IL-6

    Time frame: 30-days

    The comparison between the values of IL-6 at the four-time intervals (H0, H6-12, H24-48, D30).

  2. Change in IL-10

    Time frame: 30-days

    The comparison between the values of IL-10 at the four-time intervals (H0, H6-12, H24-48, D30).

  3. Change in IL-18

    Time frame: 30-days

    The comparison between the values of IL-18 at the four-time intervals (H0, H6-12, H24-48, D30).

  4. Change in IL-17

    Time frame: 30-days

    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).

  5. Change in Leptin

    Time frame: 30-days

    The comparison between the values of Leptin at the four-time intervals (H0, H6-12, H24-48, D30).

  6. Change in Apelin

    Time frame: 30-days

    The comparison between the values of Apelin at the four-time intervals (H0, H6-12, H24-48, D30).

  7. Change in Chemerin

    Time frame: 30-days

    The comparison between the values of Chemerin at the four-time intervals (H0, H6-12, H24-48, D30).

Sponsors and collaborators

Lead sponsor

Nicosia General Hospital

Other

Collaborators

  • Aristotle University Of Thessaloniki
  • Hippocration General Hospital

Registry information

Official study title

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

Acronym: INFINITY

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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