Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05494151
Status:
WITHDRAWN
Last Update Posted:
2022-08-11
First Post:
2022-08-06
Brief Title:
Metabolic Substrate of Patients With Myocardial Infarction With and Without Modifiable Cardiovascular Risk Factors
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
Investigation of the Metabolic Substrate of Patients With Myocardial Infarction and Derivation of a Risk Estimation Algorithm to Evaluate Cardiovascular Risk Beyond Standard Modifiable Risk Factors SMuRFs - The MetaSMuRF Study
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to unforeseen challenges in participant recruitment and retention the study was early terminated to maintain the integrity of the data and ensure ethical standards were upheld
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Meta-SMuRF
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
Detailed 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-MSMS and Hydrophilic Interaction Liquid Chromatography tandem Mass Spectrometry HILIC-MSMS 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
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-MSMS and Hydrophilic Interaction Liquid Chromatography tandem Mass Spectrometry HILIC-MSMS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None