Coronary Artery DiseaseGEOMETRY-CTANCT04185493
Coronary Artery Geometry and the Severity of Coronary Atherosclerosis
An observational study of Coronary Artery Disease and Atherosclerosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Atherosclerotic Plaque
- What is being tested?
- CCTA
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 4 Jun 2020to Sep 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients older than 18 years old at entry, of both genders, who referred for coronary CT angiography
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital, Department of Cardiology
Thessaloniki, 54636
Georgios Rampidis, MD, MSc, +306976254340, grampidi@auth.gr
Haralambos Karvounis, MD, PhD
About this study
Official title: Assessment of Coronary Artery Geometry With Coronary CT Angiography: Evaluation of Atherosclerotic Plaque Burden and Composition
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.
Read the detailed 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.
- Being tested
- CCTA
- Keywords
- Geometry, Bifurcation Angle, Cardiac Computed Tomography Angiography, Coronary Artery Disease, Vulnerable Coronary Plaque, Indexed Coronary Volume, Risk Assessment
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Plaque, Atherosclerotic, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTADiagnostic test
128-multislice CT coronary angiography and complex atherosclerotic plaque analysis with the use of CT imaging post-processing techniques.
| Study group | Role | What they receive |
|---|---|---|
| CCTA Cohort | Consecutive patients with suspected coronary artery disease and low/intermediate pre-test probability Receives: Diagnostic Test: CCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Main Coronary Artery (LMCA) angle of take-off from the aortic root
Measurement using curved Multiplanar Reconstruction (MPR) technique in advantage workstation server
Measured: 30 days
Right Coronary Artery (RCA) angle of take-off from the aortic root
Measurement using curved MPR technique in advantage workstation server
Measured: 30 days
Left Anterior Descending (LAD) / Left Circumflex (LCx) bifurcation angle
Measurement using curved MPR technique in advantage workstation server
Measured: 30 days
Indexed Coronary Volume
Calculated by dividing the total coronary volume to the left ventricle mass, both derived from CCTA (mm3/gr)
Measured: 30 days
Secondary outcomes (6)
Extent of Coronary Atherosclerosis
Total atherosclerotic plaque volume (mm3)
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
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)
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start4 Jun 2020
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki
- Investigators
- Haralambos Karvounis, MD, PhD, Study chair, AHEPA-Department of CardiologyKonstantinos Kouskouras, MD, PhD, Principal investigator, AHEPA-Department of RadiologyGeorgios Rampidis, MD, MSc, Principal investigator, AHEPA-Department of CardiologyVasileios Rafailidis, MD, PhD, Principal investigator, AHEPA-Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185493
- Sponsor's protocol ID
- GEOMETRY_29.01.2019.101068
- Acronym
- GEOMETRY-CTA
- Status last verified
- Jun 2020
- First submitted
- 1 Dec 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25983161Rampidis 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.
PubMed 31104809Ferencik 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.
PubMed 29759894Toutouzas 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.
PubMed 26419623Giannopoulos 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.
PubMed 28685252Kolossvary 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.
PubMed 29255692Pflederer 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.
PubMed 17035869Benetos 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.
PubMed 31894527Benz 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.
PubMed 31974008
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Artery Geometry With Coronary CT Angiography: Evaluation of Atherosclerotic Plaque Burden and Composition
- ClinicalTrials.gov ID
- NCT04185493
- Acronym / sponsor ID
- GEOMETRY-CTA / GEOMETRY_29.01.2019.101068
- Keywords
- Geometry, Bifurcation Angle, Cardiac Computed Tomography Angiography, Coronary Artery Disease, Vulnerable Coronary Plaque, Indexed Coronary Volume, Risk Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA Cohort | – | Diagnostic Test: CCTAConsecutive patients with suspected coronary artery disease and low/intermediate pre-test probability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients older than 18 years old at entry, of both genders, who referred for coronary CT angiography
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTA128-multislice CT coronary angiography and complex atherosclerotic plaque analysis with the use of CT imaging post-processing techniques. | Diagnostic test | CCTA Cohort |
Primary outcome
Left Main Coronary Artery (LMCA) angle of take-off from the aortic root
Time frame: 30 days
Measurement using curved Multiplanar Reconstruction (MPR) technique in advantage workstation server
Right Coronary Artery (RCA) angle of take-off from the aortic root
Time frame: 30 days
Measurement using curved MPR technique in advantage workstation server
Left Anterior Descending (LAD) / Left Circumflex (LCx) bifurcation angle
Time frame: 30 days
Measurement using curved MPR technique in advantage workstation server
Indexed Coronary Volume
Time frame: 30 days
Calculated by dividing the total coronary volume to the left ventricle mass, both derived from CCTA (mm3/gr)
6 secondary outcomes
Extent of Coronary Atherosclerosis
Time frame: 30 days
Severity of Coronary Atherosclerosis assessed by using Leiden CTA risk score
Time frame: 30 days
Severity of Coronary Atherosclerosis assessed by using Gensini score
Time frame: 30 days
Complexity of Coronary Artery Disease [CT-SYNTAX score]
Time frame: 30 days
Frequency of occurrence of high-risk plaques
Time frame: 30 days
Plaque burden assessment [Modified Duke CAD Index for coronary CTA]
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Background: PubMed 25983161Antoniadis 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.
- Background: PubMed 31104809Rampidis 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.
- Background: PubMed 29759894Ferencik 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.
- Background: PubMed 26419623Toutouzas 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.
- Background: PubMed 28685252Giannopoulos 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.
- Background: PubMed 29255692Kolossvary 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.
- Background: PubMed 17035869Pflederer 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.
- Background: PubMed 31894527Benetos 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.
- Background: PubMed 31974008Benz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haralambos Karvounis, MD, PhD study chair
AHEPA-Department of Cardiology
Konstantinos Kouskouras, MD, PhD principal investigator
AHEPA-Department of Radiology
Georgios Rampidis, MD, MSc principal investigator
AHEPA-Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios P Rampidis, MD, MSc (2310994830 ext. +30, grampidi@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Main Coronary Artery (LMCA) angle of take-off from the aortic root (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185493, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.