Coronary Artery Geometry and the Severity of Coronary Atherosclerosis

NCT ID: NCT04185493

Last Updated: 2020-06-05

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-04

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease Atherosclerosis Atherosclerotic Plaque Stable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CCTA Cohort

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

CCTA

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CCTA

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Georgios P Rampidis, MD, MSc

Academic Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haralambos Karvounis, MD, PhD

Role: STUDY_CHAIR

AHEPA-Department of Cardiology

Konstantinos Kouskouras, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AHEPA-Department of Radiology

Georgios Rampidis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

AHEPA-Department of Cardiology

Vasileios Rafailidis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AHEPA-Department of Radiology

Locations

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AHEPA University Hospital, Department of Cardiology

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Georgios P Rampidis, MD, MSc

Role: CONTACT

2310994830 ext. +30

Facility Contacts

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Georgios Rampidis, MD, MSc

Role: primary

+306976254340

References

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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.

Reference Type BACKGROUND
PMID: 25983161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31104809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29759894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26419623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28685252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29255692 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17035869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31894527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31974008 (View on PubMed)

Other Identifiers

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GEOMETRY_29.01.2019.101068

Identifier Type: -

Identifier Source: org_study_id

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