Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05535582
Status:
RECRUITING
Last Update Posted:
2022-09-10
First Post:
2022-09-03
Brief Title:
Biomarkers Predicting Acute Myocardial Infraction in Patients Without Standard Modifiable Risk Factors
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BeyondSMuRFs
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
Detailed Description:
Coronary artery disease CAD 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 it has been shown that atherogenesis as well as the subsequent inflammatory processes that can lead to AMI are not only closely related to dyslipidemia hypertension DM and smoking but also to pro-inflammatory cytokines and proteins such as Lipoprotein a LPa interleukin 6 IL-6 and other indicators of inflammation such as soluble urokinase plasminogen activator receptor suPAR This could render these biomarkers potential risk factors for the occurence of AMI Furthermore clinical entities such as various autoimmune and collagen diseases eg rheumatoid arthritis as well as psychiatric syndromes such as depression have been associated with an increased risk of atherosclerotic disease In addition newer techniques and measurements in trans-thoracic echocardiography such as GLS Global Longitudinal peak systolic strain and Myocardial Work have been linked to silent myocardial ischemia and -there is emerging evidence indicating that they- might predict future cardiovascular events Therefore the two groups of patients with SMuRFs vs SMuRF-less will be compared regarding their clinical basic and advanced laboratory and imaging fingerprints for the assessment of predictive factors leading to SMuRF-less AMIs 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 clinical laboratory and imaging 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
Patients will be enrolled in two academic hospitals and a general military hospital in Thessaloniki Greece A complete and comprehensive medical interview will be conducted in each eligible patient after revascularization From this interview the following demographic and clinical information will be obtained age sex contact information exact symptoms and disease history detailed medical history diagnostic and therapeutic interventions performed in the past and medication received In addition the patients laboratory data will be recorded on admission and during hospitalization These will include complete blood count biochemical control coagulation mechanism control hormonal control HbA1c NTproBNP HsTnT on admission higher-peak value of HsTnT and NTproBNP and LPa IL-6 suPAR levels on admission Furthermore each patient will undergo a full echocardiographic examination with a specific protocol that includes specialized and modern measurements such as Global Longitudinal Strain GLS of the left ventricle and the rest heart cavities as well as non-invasive calculation of myocardial work of the left ventricle Global Constructive Work Global Wasted Work Global Work Index Global Work Efficiency Myocardial Work 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 clinical laboratory and echocardiographic biomarkers will contribute to the early prognosis and personalized prevention of such a particular category of AMIs
Concurrently it has been shown that atherogenesis as well as the subsequent inflammatory processes that can lead to AMI are not only closely related to dyslipidemia hypertension DM and smoking but also to pro-inflammatory cytokines and proteins such as Lipoprotein a LPa interleukin 6 IL-6 and other indicators of inflammation such as soluble urokinase plasminogen activator receptor suPAR This could render these biomarkers potential risk factors for the occurence of AMI Furthermore clinical entities such as various autoimmune and collagen diseases eg rheumatoid arthritis as well as psychiatric syndromes such as depression have been associated with an increased risk of atherosclerotic disease In addition newer techniques and measurements in trans-thoracic echocardiography such as GLS Global Longitudinal peak systolic strain and Myocardial Work have been linked to silent myocardial ischemia and -there is emerging evidence indicating that they- might predict future cardiovascular events Therefore the two groups of patients with SMuRFs vs SMuRF-less will be compared regarding their clinical basic and advanced laboratory and imaging fingerprints for the assessment of predictive factors leading to SMuRF-less AMIs 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 clinical laboratory and imaging 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
Patients will be enrolled in two academic hospitals and a general military hospital in Thessaloniki Greece A complete and comprehensive medical interview will be conducted in each eligible patient after revascularization From this interview the following demographic and clinical information will be obtained age sex contact information exact symptoms and disease history detailed medical history diagnostic and therapeutic interventions performed in the past and medication received In addition the patients laboratory data will be recorded on admission and during hospitalization These will include complete blood count biochemical control coagulation mechanism control hormonal control HbA1c NTproBNP HsTnT on admission higher-peak value of HsTnT and NTproBNP and LPa IL-6 suPAR levels on admission Furthermore each patient will undergo a full echocardiographic examination with a specific protocol that includes specialized and modern measurements such as Global Longitudinal Strain GLS of the left ventricle and the rest heart cavities as well as non-invasive calculation of myocardial work of the left ventricle Global Constructive Work Global Wasted Work Global Work Index Global Work Efficiency Myocardial Work 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 clinical laboratory and echocardiographic 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