Clinical trial NCT04580173: Correlation of Clinical Types and Complexity of Coronary Artery Disease With Patients' Metabolic Profile
Official title: Correlation of Clinical Types and Complexity of Coronary Artery Disease With Patients' Metabolic Profile
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
metabolomics
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
Collaborators: name: ANALYSIS MEDICAL SA
name: Aristotle University Of Thessaloniki
First posted: 2020-10-08
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between metabolic profile and the SYNTAX score
timeFrame: 12 months
Secondary outcomes:
measure: Concentration of serum ceramide species
timeFrame: 12 months
measure: Concentration of serum acyl-carnitines
timeFrame: 12 months
measure: Concentration of serum total fatty acids
timeFrame: 12 months
measure: Concentration of serum selective protein markers
timeFrame: 12 months
measure: Major Adverse Cardiovascular and Cerebrovascular Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: AHEPA University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.