NCT04580173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

1.9 years

First QC Date

October 2, 2020

Last Update Submit

October 9, 2020

Conditions

Keywords

coronary artery diseasemetabolomics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Concentration of serum ceramide species

    12 months

  • Concentration of serum acyl-carnitines

    12 months

  • Concentration of serum total fatty acids

    12 months

  • Concentration of serum selective protein markers

    12 months

  • Major Adverse Cardiovascular and Cerebrovascular Events

    12 months

Study Arms (4)

SYNTAX score = 0

Patients with nonobstructive CAD (≤50 % diameter stenosis)

Diagnostic Test: metabolomics analysis

0 < SYNTAX score <=22

Low SYNTAX group

Diagnostic Test: metabolomics analysis

23<=SYNTAX score<=32

Intermediate SYNTAX group

Diagnostic Test: metabolomics analysis

SYNTAX score>=33

High SYNTAX group

Diagnostic Test: metabolomics analysis

Interventions

metabolomics analysisDIAGNOSTIC_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 <=2223<=SYNTAX score<=32SYNTAX score = 0SYNTAX score>=33

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Patients giving voluntary written consent to participate in the study
  • Adults
  • Patients without previous history of coronary artery disease
  • Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes

You may not qualify if:

  • Cardiac Arrest at admission
  • Patients with serious concurrent disease and life expectancy of \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

RECRUITING

Related Publications (4)

  • 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.

    PMID: 19758907BACKGROUND
  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Georgios Sianos, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Georgios Sianos, Associate Professor of Cardiology MD, PhD, FESC, AHEPA University Hospital

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 8, 2020

Study Start

July 12, 2019

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations