Correlation of Clinical Types and Complexity of Coronary Artery Disease With Patients' Metabolic Profile
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- AHEPA University Hospital
- Enrollment
- 1,050
- Locations
- 1
- Primary Endpoint
- Relationship between metabolic profile and the SYNTAX score
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients giving voluntary written consent to participate in the study
- •Patients without previous history of coronary artery disease
- •Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes
Exclusion Criteria
- •Cardiac Arrest at admission
- •Patients with serious concurrent disease and life expectancy of < 1 year
Outcomes
Primary Outcomes
Relationship between metabolic profile and the SYNTAX score
Time Frame: 12 months
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.
Secondary Outcomes
- Concentration of serum total fatty acids(12 months)
- Concentration of serum acyl-carnitines(12 months)
- Concentration of serum selective protein markers(12 months)
- Concentration of serum ceramide species(12 months)
- Major Adverse Cardiovascular and Cerebrovascular Events(12 months)
Investigators
Georgios Sianos
Georgios Sianos, Associate Professor of Cardiology MD, PhD, FESC, AHEPA University Hospital
AHEPA University Hospital