Biomarkers Predicting Acute Myocardial Infraction in Patients Without Standard Modifiable Risk Factors

NCT05535582 | Completed

• 1 other identifier: 64000-20/4/2022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary heart disease (CHD) is the leading cause of mortality worldwide. Every year, millions of people suffer its most adverse manifestation, an acute myocardial infraction (AMI). The majority of these patients present at least one of the standard modifiable risk factors (SMuRFs). These include smoking, hypertension, dyslipidemia, and diabetes mellitus (DM). However, emerging scientific evidence recognizes a clinically significant proportion of patients presenting with life-threatening AMI without any SMuRF (SMuRF-less patients). This proportion of patients with ACS without SMuRF appears to be increasing during the last two decades and has recently been reported as high as 20% (of total AMIs). To date, there are no scientific data capable of highlighting specific risk factors-biomarkers responsible for the development of AMIs SMuRF-less patients. Therefore, two groups of patients with AMI (with SMuRFs vs SMuRF-less) will be compared regarding their clinical, laboratory and imaging (echocardiographic and angiographic) profile, and possible predictive factors leading to SMuRF-less AMI will be evaluated. On the basis of the above, the aim is to prospectively analyze a cohort of well-characterized patients with AMI. The rationale of the study is to investigate potential correlations between metabolic profile of patients and SMuRF-less AMI. This could lead to the development of predictive risk stratification algorithms for patients without SMuRFs and coronary artery disease.

Conditions

Cardiovascular Diseases; Acute Myocardial Infarction; Acute Coronary Syndrome; Metabolic Disturbance

Keywords

Standard modifiable risk factors; Acute Myocardial Infarction; Acute Coronary Syndrome; Clinical Profile; Laboratory Biomarkers; Echocardiographic biomarkers

Outcome Measures

Primary Outcomes (1)

• Clinical, laboratory and imaging biomarkers associated with SMuRF-less myocardial infraction

  Identification of differences in the prevalence of clinical features, or/and differences in the levels of laboratory and echocardiographic biomarkers between SMuRF-less myocardial infractions and myocardial infractions in patients with SMuRFs. Each parameter/biomarker will be compared between the two groups and therefore assessments are of the same unit of measurement (e.g. difference in BMI between SMuRF-less patients and patients with SMuRFs or difference in the percentage of history of autoimmune diseass between SMuRF-less patients and patients with SMuRFs or difference in serum levels of Lipoprotein a between these two groups)

  2 years

Study Arms (2)

Patients with SMuRFs

Patients with acute myocardial infraction with a history of at least one standard modifiable risk factor (SMuRF; smoking, diabetes mellitus, dyslipidemia, hypertension)

Diagnostic Test: Investigation of clinical, laboratory and imaging profile

SMuRF-less Patients

Patients with acute myocardial infraction without history of any SMuRF

Diagnostic Test: Investigation of clinical, laboratory and imaging profile

Interventions

Investigation of clinical, laboratory and imaging profile DIAGNOSTIC_TEST

Complete and comprehensive medical interview will be conducted in each eligible patient after revascularization. In addition, patient's laboratory data will be recorded on admission and during hospitalization. Furthermore, each patient will undergo a full echocardiographic examination with a specific protocol.

Patients with SMuRFs; SMuRF-less Patients

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \>25years old presenting with acute myocardial infraction with or without ST elevation within the previous 4 weeks, with at least one angiographically-testified stenosis\>50% in a major epicardial coronary artery

You may qualify if:

• Age \>25 years
• Hospitalization for acute myocardial infarction (AMI) with or without ST elevation (based on Fourth Universal Definition of Myocardial Infarction)
• Coronary angiography before or after hospitalization for AMI, in which at least one stenosis \>50% in a major epicardial coronary artery (left anterior descending artery, left circumflex artery, right coronary artery) or a branch thereof with a diameter of at least 2 mm was observed.

You may not qualify if:

• Inability or refusal to provide informed consent
• Age \>90 years
• History of hospitalization due to AMI prior to the present AMI
• History of coronary revascularization prior to the present AMI AMI
• Known history of hypertension and/or antihypertensive treatment prior to AMI
• Use of tobacco products on a systematic basis for up to \<60 months (5 years) before AMI
• History of diabetes mellitus type 1 or 2 and/or treatment with antidiabetic tablets or insulin before AMI or diagnosis of diabetes mellitus based on HbA1c during AMI hospitalization
• Known hypercholesterolemia (total chol \>200 mg/dl / LDLc \>150 mg/dl) or treatment with statins or PCSK9is, before AMI

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Hippokration General University Hospital of Thessaloniki

Thessaloniki, Central Macedonia, 54642, Greece

Location

Related Publications (1)

• Moysidis DV, Daios S, Anastasiou V, Liatsos AC, Papazoglou AS, Karagiannidis E, Kamperidis V, Makedou K, Thisiadou A, Karalazou P, Papadakis M, Savopoulos C, Ziakas A, Giannakoulas G, Vassilikos V, Giannopoulos G. Association of clinical, laboratory and imaging biomarkers with the occurrence of acute myocardial infarction in patients without standard modifiable risk factors - rationale and design of the "Beyond-SMuRFs Study". BMC Cardiovasc Disord. 2023 Mar 23;23(1):149. doi: 10.1186/s12872-023-03180-4.

  PMID: 36959584 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood chemistry test

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• Georgios Giannopoulos, Associate Professor

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Fellow

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 10, 2022
• Study Start: April 10, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)