Correlation of Clinical Types and Complexity of Coronary Artery Disease With Patients' Metabolic Profile

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: metabolomics analysis

• Registration Number: NCT04580173
• Lead Sponsor: AHEPA University Hospital

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 Timeline

• Study Start: 2019-07-12
• Status Verified: 2020-10
• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-08
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-12
• Primary Completion: 2021-06
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1. Patients giving voluntary written consent to participate in the study
2. Adults
3. Patients without previous history of coronary artery disease
4. 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

1. Cardiac Arrest at admission
2. Patients with serious concurrent disease and life expectancy of < 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SYNTAX score = 0	metabolomics analysis	Patients with nonobstructive CAD (≤50 % diameter stenosis)
23<=SYNTAX score<=32	metabolomics analysis	Intermediate SYNTAX group
SYNTAX score>=33	metabolomics analysis	High SYNTAX group
0 < SYNTAX score <=22	metabolomics analysis	Low SYNTAX group

Primary Outcome Measures

Name	Time	Method
Relationship between metabolic profile and the SYNTAX score	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 Outcome Measures

Name	Time	Method
Concentration of serum total fatty acids	12 months	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.
Concentration of serum acyl-carnitines	12 months	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.
Concentration of serum selective protein markers	12 months	Quantification of selective protein markers (Galectictin-3, NGAL, Adiponectin, ApoB/ ApoΑ-Ι)
Concentration of serum ceramide species	12 months	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.
Major Adverse Cardiovascular and Cerebrovascular Events	12 months	Cardiovascular death, myocardial infarction, stent thrombosis, revascularization and stroke

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloníki, Greece