Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05494151 |
| Other study ID # |
64000/20-4-2022 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2022 |
| Est. completion date |
September 1, 2026 |
Study information
| Verified date |
August 2022 |
| Source |
Aristotle University Of Thessaloniki |
| Contact |
Dimitrios Moysidis |
| Phone |
+306984383937 |
| Email |
dimoysidis[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
Blood tests (blood chemistry) will be received from each patient on admission and will be
analyzed to assess patients' metabolic profile. In order to achieve full coverage of all
compounds, different analytical platforms and methods, such as Enzyme-LInked Immunosorbent
Assay (ELISA), Reversed Phase Liquid Chromatography tandem Mass Spectrometry (RPLC-MS/MS) and
Hydrophilic Interaction Liquid Chromatography tandem Mass Spectrometry (HILIC-MS/MS) will be
applied. Univariate and multivariate analysis with linear and logistic regression models will
be used to investigate independent prognostic factors contributing to the occurrence of
SMuRF-less AMIs. The potential application in daily clinical practice of a derived clinical
predictive model-algorithm, possibly including a new panel of metabolomic biomarkers, will
contribute to the early prognosis and personalized prevention of such a particular category
of AMIs.
