Coronary Artery Geometry and the Severity of Coronary Atherosclerosis

NCT04185493 | Unknown

• 1 other identifier: GEOMETRY_29.01.2019.101068
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the potential association of coronary artery geometry, based on coronary CT angiography (CCTA), with the complexity and the severity of coronary atherosclerosis.

Conditions

Coronary Artery Disease; Atherosclerosis; Atherosclerotic Plaque; Stable Angina

Keywords

Geometry; Bifurcation Angle; Cardiac Computed Tomography Angiography; Coronary Artery Disease; Vulnerable Coronary Plaque; Indexed Coronary Volume; Risk Assessment

Outcome Measures

Primary Outcomes (4)

• Left Main Coronary Artery (LMCA) angle of take-off from the aortic root

  Measurement using curved Multiplanar Reconstruction (MPR) technique in advantage workstation server

  30 days

• Right Coronary Artery (RCA) angle of take-off from the aortic root

  Measurement using curved MPR technique in advantage workstation server

  30 days

• Left Anterior Descending (LAD) / Left Circumflex (LCx) bifurcation angle

  Measurement using curved MPR technique in advantage workstation server

  30 days

• Indexed Coronary Volume

  Calculated by dividing the total coronary volume to the left ventricle mass, both derived from CCTA (mm3/gr)

  30 days

Secondary Outcomes (6)

• Extent of Coronary Atherosclerosis

  30 days

• Severity of Coronary Atherosclerosis assessed by using Leiden CTA risk score

  30 days

• Severity of Coronary Atherosclerosis assessed by using Gensini score

  30 days

• Complexity of Coronary Artery Disease [CT-SYNTAX score]

  30 days

• Frequency of occurrence of high-risk plaques

  30 days

Study Arms (1)

CCTA Cohort

Consecutive patients with suspected coronary artery disease and low/intermediate pre-test probability

Diagnostic Test: CCTA

Interventions

CCTA DIAGNOSTIC_TEST

128-multislice CT coronary angiography and complex atherosclerotic plaque analysis with the use of CT imaging post-processing techniques.

CCTA Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients older than 18 years old at entry, of both genders, who referred for coronary CT angiography

You may qualify if:

• Patients referred for cardiac CT angiography
• Patients without previous history of Coronary Artery Disease (CAD)
• Age ≥ 18 years
• Patients giving voluntary written consent to participate in the study

You may not qualify if:

• Pregnancy or breast-feeding
• Patients with serious concurrent disease and life expectancy of \< 1 year
• Patients with a previous history of CAD
• Patients who refuse to give written consent for participation in the study

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital, Department of Cardiology

Thessaloniki, 54636, Greece

RECRUITING

Related Publications (9)

• Antoniadis AP, Giannopoulos AA, Wentzel JJ, Joner M, Giannoglou GD, Virmani R, Chatzizisis YS. Impact of local flow haemodynamics on atherosclerosis in coronary artery bifurcations. EuroIntervention. 2015;11 Suppl V:V18-22. doi: 10.4244/EIJV11SVA4.

  PMID: 25983161 BACKGROUND

• Rampidis GP, Benetos G, Benz DC, Giannopoulos AA, Buechel RR. A guide for Gensini Score calculation. Atherosclerosis. 2019 Aug;287:181-183. doi: 10.1016/j.atherosclerosis.2019.05.012. Epub 2019 May 10. No abstract available.

  PMID: 31104809 BACKGROUND

• Ferencik M. About the twists and turns: Relationship of coronary artery geometry and atherosclerosis. J Cardiovasc Comput Tomogr. 2018 May-Jun;12(3):261-262. doi: 10.1016/j.jcct.2018.04.004. Epub 2018 Apr 24. No abstract available.

  PMID: 29759894 BACKGROUND

• Toutouzas K, Benetos G, Karanasos A, Chatzizisis YS, Giannopoulos AA, Tousoulis D. Vulnerable plaque imaging: updates on new pathobiological mechanisms. Eur Heart J. 2015 Dec 1;36(45):3147-54. doi: 10.1093/eurheartj/ehv508. Epub 2015 Sep 28.

  PMID: 26419623 BACKGROUND

• Giannopoulos AA, Benz DC, Grani C, Buechel RR. Imaging the event-prone coronary artery plaque. J Nucl Cardiol. 2019 Feb;26(1):141-153. doi: 10.1007/s12350-017-0982-0. Epub 2017 Jul 6.

  PMID: 28685252 BACKGROUND

• Kolossvary M, Szilveszter B, Merkely B, Maurovich-Horvat P. Plaque imaging with CT-a comprehensive review on coronary CT angiography based risk assessment. Cardiovasc Diagn Ther. 2017 Oct;7(5):489-506. doi: 10.21037/cdt.2016.11.06.

  PMID: 29255692 BACKGROUND

• Pflederer T, Ludwig J, Ropers D, Daniel WG, Achenbach S. Measurement of coronary artery bifurcation angles by multidetector computed tomography. Invest Radiol. 2006 Nov;41(11):793-8. doi: 10.1097/01.rli.0000239318.88270.9f.

  PMID: 17035869 BACKGROUND

• Benetos G, Buechel RR, Goncalves M, Benz DC, von Felten E, Rampidis GP, Clerc OF, Messerli M, Giannopoulos AA, Gebhard C, Fuchs TA, Pazhenkottil AP, Kaufmann PA, Grani C. Coronary artery volume index: a novel CCTA-derived predictor for cardiovascular events. Int J Cardiovasc Imaging. 2020 Apr;36(4):713-722. doi: 10.1007/s10554-019-01750-2. Epub 2020 Jan 1.

  PMID: 31894527 BACKGROUND

• Benz DC, Benetos G, Rampidis G, von Felten E, Bakula A, Sustar A, Kudura K, Messerli M, Fuchs TA, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Validation of deep-learning image reconstruction for coronary computed tomography angiography: Impact on noise, image quality and diagnostic accuracy. J Cardiovasc Comput Tomogr. 2020 Sep-Oct;14(5):444-451. doi: 10.1016/j.jcct.2020.01.002. Epub 2020 Jan 13.

  PMID: 31974008 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Plaque, Atherosclerotic; Angina, Stable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Haralambos Karvounis, MD, PhD

  AHEPA-Department of Cardiology

  STUDY CHAIR

• Konstantinos Kouskouras, MD, PhD

  AHEPA-Department of Radiology

  PRINCIPAL INVESTIGATOR

• Georgios Rampidis, MD, MSc

  AHEPA-Department of Cardiology

  PRINCIPAL INVESTIGATOR

• Vasileios Rafailidis, MD, PhD

  AHEPA-Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios P Rampidis, MD, MSc

CONTACT

2310994830; grampidi@auth.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Fellow

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 4, 2019
• Study Start: June 4, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

GR (1)