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

Coronary Artery Disease Clinical Trial

— CorLipid  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04580173
• Other study ID #: 95753
• Status: Recruiting
• Start date: July 12, 2019
• Est. completion date: August 2021

Study information

• Verified date: October 2020
• Source: AHEPA University Hospital
• Contact: Georgios Sianos, PhD
• Phone: 2310994837
• Email: gsianos[@]auth.gr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: August 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• metabolomics analysis
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.

Locations

Country	Name	City	State
Greece	AHEPA University Hospital	Thessaloníki

Sponsors (4)

Lead Sponsor	Collaborator
AHEPA University Hospital	ANALYSIS MEDICAL SA, Laboratory of Analytical Chemistry, Department of Chemistry, Aristotle University of Thessaloniki, Laboratory of Forensic Medicine and Toxicology, Medical School, Aristotle University of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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/ Apolipoprotein?-?) 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
Secondary	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
Secondary	Concentration of serum acyl-carnitines	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
Secondary	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
Secondary	Concentration of serum selective protein markers	Quantification of selective protein markers (Galectictin-3, NGAL, Adiponectin, ApoB/ Apo?-?)	12 months
Secondary	Major Adverse Cardiovascular and Cerebrovascular Events	Cardiovascular death, myocardial infarction, stent thrombosis, revascularization and stroke	12 months