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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: metabolomics analysis

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 Type: Observational
• Enrollment (Anticipated): 1050

Contacts and Locations

• Study Contact: Name: Georgios Sianos, PhD; Phone Number: 0030 2310994837; Email: gsianos@auth.gr

Study Locations

• Greece
  • Thessaloníki, Greece, 54636
    • Recruiting
    • Ahepa University Hospital
    • Contact: Georgios Sianos, MD PhD FESC; Phone Number: 0030 2310994837; Email: gsianos@auth.gr
    • Principal Investigator: Georgios Sianos, PhD
    • Principal Investigator: Georgios Theodoridis, PhD
    • Principal Investigator: Helen Gika, PhD
    • Sub-Investigator: Efstratios Karagiannidis, MSc
    • Sub-Investigator: Eleftherios Panteris, PhD
    • Sub-Investigator: Georgios Sofidis, PhD
    • Sub-Investigator: Olga Deda, PhD
    • Sub-Investigator: Olga Begou, PhD
    • Sub-Investigator: Thomais Mouskeftara, MSc
    • Sub-Investigator: Thomas Meikopoulos, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SYNTAX score = 0; Patients with nonobstructive CAD (≤50 % diameter stenosis)	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.
0 < SYNTAX score <=22; Low SYNTAX group	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.
23<=SYNTAX score<=32; Intermediate SYNTAX group	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.
SYNTAX score>=33; High SYNTAX group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AHEPA University Hospital
• Collaborators: ANALYSIS MEDICAL SA; Laboratory of Forensic Medicine and Toxicology, Medical School, Aristotle University of Thessaloniki; Laboratory of Analytical Chemistry, Department of Chemistry, Aristotle University of Thessaloniki

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: coronary artery disease; metabolomics
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 95753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The decision to share or not individual participant data with other researchers will depend on the purpose and the scope of the proposed research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No