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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04580173
Other study ID # 95753
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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