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| Name | Class |
|---|---|
| ANALYSIS MEDICAL SA | UNKNOWN |
| Aristotle University Of Thessaloniki | OTHER |
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The purpose of the research project is to investigate the potential association of the complexity and the severity of coronary artery disease (as assessed via SYNTAX score) with patients' metabolic profile. The aim of the study is to combine biochemical, clinical and laboratory data in order to create an algorithm that will enable an individualized therapeutic patient approach.
The objective of this observational study is to expand our knowledge on the biochemical process and pathogenesis of atherogenesis and to recognize clinically important metabolic biomarkers correlated with the severity and clinical presentation of Coronary Artery Disease (CAD). 1050 patients who will undergo coronary angiography will be enrolled in the study. SYNTAX score will be calculated for all participants and their blood samples will be collected before coronary angiography. Metabolomics-based analysis will be performed in order to confirm CAD prognostic biomarkers previously reported in the literature and to investigate their correlations with CAD clinical data. The ultimate aim of this study is to predict the risk of cardiovascular events by incorporating metabolomic information into the SYNTAX score and provide personalized therapeutic guidance to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNTAX score = 0 | Patients with nonobstructive CAD (≤50 % diameter stenosis) |
| |
| 0 < SYNTAX score <=22 | Low SYNTAX group |
| |
| 23<=SYNTAX score<=32 | Intermediate SYNTAX group |
| |
| SYNTAX score>=33 | High SYNTAX group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metabolomics analysis | Diagnostic Test | Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between metabolic profile and the SYNTAX score | Serum metabolomic biomarkers (ceramides, acyl-carnitines, total fatty acids and protein markers: Galectin-3, Neutrophil Gelatinase-Associated Lipocalin, Adiponectin, ApolipoproteinB/ ApolipoproteinΑ-Ι) will be quantified using metabolomics-based methods and enzyme-linked immunosorbent assay. The SYNTAX score will be calculated for all patients. Correlation between patients' metabolic profile and the SYNTAX score will be performed. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of serum ceramide species | Quantification of serum ceramide species (C18:0/16:0, C18:0/18:0, C18:0/24:0 and C18:0/24:1) using a developed Ultra-high performance liquid chromatography tandem mass spectrometry method. | 12 months |
| Concentration of serum acyl-carnitines |
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Inclusion Criteria:
Exclusion Criteria:
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Adults, of both genders, who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes will be studied. Patients with a previous history of coronary artery disease will be excluded. The study includes subjects who 1) have suspected CAD and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (without previous history of CAD).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Sianos, PhD | Contact | 2310994837 | 0030 | gsianos@auth.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital | Recruiting | Thessaloniki | 54636 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19758907 | Background | Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. No abstract available. | |
| 35525960 | Derived | Karagiannidis E, Moysidis DV, Papazoglou AS, Panteris E, Deda O, Stalikas N, Sofidis G, Kartas A, Bekiaridou A, Giannakoulas G, Gika H, Theodoridis G, Sianos G. Prognostic significance of metabolomic biomarkers in patients with diabetes mellitus and coronary artery disease. Cardiovasc Diabetol. 2022 May 7;21(1):70. doi: 10.1186/s12933-022-01494-9. |
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The decision to share or not individual participant data with other researchers will depend on the purpose and the scope of the proposed research
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Quantification of serum acyl-carnitines (C2, C3, C4, isoC4, C5, isoC5, C6, C8, C10, C12, C14, C16, C18, C18:1 C18:2) using a developed hydrophilic interaction chromatography tandem mass spectrometry method. |
| 12 months |
| Concentration of serum total fatty acids | Quantification of total fatty acids (C10:0, C12:0, C14:0, C15:0, C16:0, C16:1, C17:0, C18:0, C18:1 cis, C18:2 cis, C20:0, C18:3 n6, C18:3 n3, C20:1, C20:2, C22:0, C20:3 n6, C22:1 & C20:4, C23:0, C20:5, C24:0, C24:1, C22:6) using a developed gas chromatography with flame-ionization method. | 12 months |
| Concentration of serum selective protein markers | Quantification of selective protein markers (Galectictin-3, NGAL, Adiponectin, ApoB/ ApoΑ-Ι) | 12 months |
| Major Adverse Cardiovascular and Cerebrovascular Events | Cardiovascular death, myocardial infarction, stent thrombosis, revascularization and stroke | 12 months |
| 35327546 | Derived | Deda O, Panteris E, Meikopoulos T, Begou O, Mouskeftara T, Karagiannidis E, Papazoglou AS, Sianos G, Theodoridis G, Gika H. Correlation of Serum Acylcarnitines with Clinical Presentation and Severity of Coronary Artery Disease. Biomolecules. 2022 Feb 23;12(3):354. doi: 10.3390/biom12030354. |
| 33557756 | Derived | Karagiannidis E, Sofidis G, Papazoglou AS, Deda O, Panteris E, Moysidis DV, Stalikas N, Kartas A, Papadopoulos A, Stefanopoulos L, Karvounis H, Gika H, Theodoridis G, Sianos G. Correlation of the severity of coronary artery disease with patients' metabolic profile- rationale, design and baseline patient characteristics of the CorLipid trial. BMC Cardiovasc Disord. 2021 Feb 8;21(1):79. doi: 10.1186/s12872-021-01865-2. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |