Metabolic Substrate of Patients With Myocardial Infarction With and Without Modifiable Cardiovascular Risk Factors

NCT05494151 | Withdrawn

• 1 other identifier: 64000/20-4-2022
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. Concurrently, metabolomics is rapidly evolving as a novel technique of studying small molecule substrates, intermediates and products of cell metabolism. This technique could be utilized to flag patients with higher risk for increased atherosclerotic burden, and subsequent future adverse clinical events. Besides the already established biomarkers, several metabolomic indicators, such as ceramides (C16, C18 και C24), acylcarnitines, apolipoproteins (ApoΒ and ApoA1) and adiponectin, have been separately shown to increase the risk for coronary artery disease development and progression. Therefore, the two groups of patients (with SMuRFs vs SMuRF-less) will be compared regarding their metabolic fingerprints -specifically the aforementioned novel metabolomic biomarkers- 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

Myocardial Infarction; Acute Coronary Syndrome; Standard modifiable risk factor; Metabolomic biomarkers

Outcome Measures

Primary Outcomes (1)

• Metabolomic biomarkers associated with SMuRF-less myocardial infraction

  Identification of differences in metabolomic biomarkers' levels (metabolic substrate) between SMuRF-less myocardial infractions and myocardial infractions in patients with SMuRFs

  3 years

Study Arms (2)

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 the metabolic substrate

SMuRF-less

Patients with acute myocardial infraction without history of any SMuRF

Diagnostic Test: Investigation of the metabolic substrate

Interventions

Investigation of the metabolic substrate DIAGNOSTIC_TEST

A blood sample will be received from each patient to assess novel metabolomic biomarkers' levels at the time of acute myocardial infraction

SMuRF-less; SMuRFs

Eligibility Criteria

• Age: 25 Years - 80 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) within the previous 4 weeks
• 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 \>80 years
• History of hospitalization due to AMI prior to the present AMI
• History of coronary revascularization prior to the present AMI AMI
• Previous coronary angiography (prior to the present AMI) showing \>50% stenosis in a major epicardial coronary artery
• Known history of hypertension and/or antihypertensive treatment prior to AMI
• Use of tobacco products on a systematic basis for up to \<12 months 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Centrifuged blood chemistry test

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Dimitrios Moysidis

  Aristotle University Of Thessaloniki

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: October 15, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 23, 2024

Record last verified: 2024-08