NCT05535582Completed
Biomarkers Predicting Acute Myocardial Infraction in Patients Without Standard Modifiable Risk Factors
Association of Clinical, Laboratory and Imaging Biomarkers With the Occurrence of Acute Myocardial Infraction in Patients Without Standard Modifiable Risk Factors (The Beyond-SMuRFs Study)
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1000 (actual)
- First submitted
- 3 Sept 2022
- Start date
- 10 Apr 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Aristotle University Of Thessaloniki
- Diseases
- Coronary artery disease
- NCT number
- NCT05535582
What you commit to
- Study type: Observational
- Participants enrolled: 1000
- From 10 Apr 2022 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- 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
Age
- Age \>90 years
Other
- Inability or refusal to provide informed consent
- Use of tobacco products on a systematic basis for up to \<60 months (5 years) before AMI
Who the study is looking for
- 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.
Age in the registry: 25 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hippokration General University Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.