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

NCT ID: NCT04580173

Last Updated: 2020-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-12

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SYNTAX score = 0

Patients with nonobstructive CAD (≤50 % diameter stenosis)

metabolomics analysis

Intervention Type DIAGNOSTIC_TEST

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

metabolomics analysis

Intervention Type DIAGNOSTIC_TEST

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

metabolomics analysis

Intervention Type DIAGNOSTIC_TEST

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

metabolomics analysis

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ANALYSIS MEDICAL SA

UNKNOWN

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role collaborator

AHEPA University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Georgios Sianos

Georgios Sianos, Associate Professor of Cardiology MD, PhD, FESC, AHEPA University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AHEPA University Hospital

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Georgios Sianos, PhD

Role: CONTACT

2310994837 ext. 0030

Facility Contacts

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Georgios Sianos, MD PhD FESC

Role: primary

2310994837 ext. 0030

References

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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.

Reference Type BACKGROUND
PMID: 19758907 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35525960 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35327546 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33557756 (View on PubMed)

Other Identifiers

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95753

Identifier Type: -

Identifier Source: org_study_id

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