Coronary Artery Geometry and the Severity of Coronary Atherosclerosis

Coronary Artery Disease Clinical Trial

— GEOMETRY-CTA  

Official title:

Assessment of Coronary Artery Geometry With Coronary CT Angiography: Evaluation of Atherosclerotic Plaque Burden and Composition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185493
• Other study ID #: GEOMETRY_29.01.2019.101068
• Status: Recruiting
• Start date: June 4, 2020
• Est. completion date: September 2021

Study information

• Verified date: June 2020
• Source: Aristotle University Of Thessaloniki
• Contact: Georgios P Rampidis, MD, MSc
• Phone: 2310994830
• Email: grampidi[@]auth.gr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The angulation of the side branch take-off has been reported to influence the severity of atherosclerosis in coronary bifurcations, as larger angles have been associated with increased plaque burden. Data from computational fluid dynamics studies have confirmed this finding by demonstrating that even in the absence of alterations in the amount of branch flow, a wide angle between the side branches intensifies flow perturbations, increases the spatial endothelial shear stress (ESS) variations in the bifurcation region and the low ESS in the lateral walls, thereby augmenting the atherosclerosis-prone environment. The magnitude of reversed flow, the extension of the recirculation zone and the duration of flow separation during the pulse cycle comprise other haemodynamic parameters which are important in atherogenesis and are amplified by an increased bifurcation angle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Angina, Stable
• Atherosclerosis
• Atherosclerotic Plaque
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Plaque, Atherosclerotic
• Stable Angina

Intervention

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

Locations

Country	Name	City	State
Greece	AHEPA University Hospital, Department of Cardiology	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & 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. Review. — View Citation

Benetos G, Buechel RR, Gonçalves M, Benz DC, von Felten E, Rampidis GP, Clerc OF, Messerli M, Giannopoulos AA, Gebhard C, Fuchs TA, Pazhenkottil AP, Kaufmann PA, Gräni 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. — View Citation

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 Jan 13. pii: S1934-5925(19)30464-2. doi: 10.1016/j.jcct.2020.01.002. [Epub ahead of print] — View Citation

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. — View Citation

Giannopoulos AA, Benz DC, Gräni 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. — View Citation

Kolossváry 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Right Coronary Artery (RCA) angle of take-off from the aortic root	Measurement using curved MPR technique in advantage workstation server	30 days
Primary	Left Anterior Descending (LAD) / Left Circumflex (LCx) bifurcation angle	Measurement using curved MPR technique in advantage workstation server	30 days
Primary	Indexed Coronary Volume	Calculated by dividing the total coronary volume to the left ventricle mass, both derived from CCTA (mm3/gr)	30 days
Secondary	Extent of Coronary Atherosclerosis	Total atherosclerotic plaque volume (mm3)	30 days
Secondary	Severity of Coronary Atherosclerosis assessed by using Leiden CTA risk score	Leiden CTA risk score incorporates the presence, extent, severity, location, and composition of coronary artery disease (CAD). Leiden CTA score is calculated using the following approach. First, the presence of CAD is determined in each segment. When plaque is absent the score is 0. When plaque is present a score of 1.1, 1.2 or 1.3 is given according to plaque composition (calcified, noncalcified, and mixed plaque, respectively). Subsequently, this score is multiplied by a weight factor for the location of the segment in the coronary artery tree (0.5 through 6 according to vessel, proximal location and system dominance) and multiplied by a weight factor for stenosis severity (1.4 for =50% stenosis and 1.0 for stenosis <50%). The final score (range 0 to 42) is calculated by addition of the individual segment scores.	30 days
Secondary	Severity of Coronary Atherosclerosis assessed by using Gensini score	The relative severity of a lesion is indicated using a score of 1 for 1-25% obstruction and doubling that number as the severity of obstruction progresses with each step in the 25-50-75-90-99-100% diameter reduction. Thus, the severity score for each lesion may range from 1 to 32. Furthermore, the score weighed according to the usual blood flow to the left ventricle in each vessel or vessel segment. A multiplying factor is applied to each lesion score based upon its location in the coronary tree, depending on the functional significance of the area supplied by that segment. If a segment is totally occluded or 99% stenosed and receiving collaterals, a collateral adjustment factor is used, and the adjustment is reduced by the extent of disease in the vessel that is the source of collaterals. The final score is the sum of all the lesion scores.	30 days
Secondary	Complexity of Coronary Artery Disease [CT-SYNTAX score]	CCTA-derived SYNTAX score (CT-SYNTAX score) is a lesion-based grading tool to characterise the coronary vasculature with respect to the number of lesions and their functional impact, location, and complexity. Higher SYNTAX scores, indicative of more complex disease, are hypothesized to represent a bigger therapeutic challenge and to have potentially worse prognosis.	30 days
Secondary	Frequency of occurrence of high-risk plaques	Frequency (%) of occurrence of high-risk plaque features (HU < 30, Remodelling Index > 1.1, napkin-ring sign & spotty calcium)	30 days
Secondary	Plaque burden assessment [Modified Duke CAD Index for coronary CTA]	Patients are assigned a risk score between 0-100 based on former patient prognosis data. The score is an extension of the 3-vessel disease score. It also incorporates stenosis severity and calculates with left main stenosis and proximal left anterior descending stenosis. There is a significant difference between patients' cumulative survival for the different categories. Left main plaque with any additional moderate or severe stenosis indicates the worst outcome.	30 days