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NCT06404515
ASCVD, Acute Coronary Syndrome
New York, United States
View Trial DetailsNCT Number: NCT06065514
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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Notify Me18 year and older
All sexes
Observational
Nicosia General Hospital, Nicosia, Cyprus
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
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).
Time frame: 6-months
The comparison between the values of the studied biomarkers at the four-time intervals (H0, H6-12, H24-48, D30).
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
Time frame: 30-days
The comparison between the values of IL-6 at the four-time intervals (H0, H6-12, H24-48, D30).
Time frame: 30-days
The comparison between the values of IL-10 at the four-time intervals (H0, H6-12, H24-48, D30).
Time frame: 30-days
The comparison between the values of IL-18 at the four-time intervals (H0, H6-12, H24-48, D30).
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).
Time frame: 30-days
The comparison between the values of Leptin at the four-time intervals (H0, H6-12, H24-48, D30).
Time frame: 30-days
The comparison between the values of Apelin at the four-time intervals (H0, H6-12, H24-48, D30).
Time frame: 30-days
The comparison between the values of Chemerin at the four-time intervals (H0, H6-12, H24-48, D30).
Nicosia General Hospital
Other
The Complex Role of the Inflammation Response Following an Acute Myocardial Infarction: the INFINITY (INFlammatIoN amI sTudY)
Acronym: INFINITY
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View the official ClinicalTrials.gov record (opens in a new tab)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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