- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185493
Coronary Artery Geometry and the Severity of Coronary Atherosclerosis (GEOMETRY-CTA)
June 4, 2020 updated by: Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Georgios P Rampidis, MD, MSc
- Phone Number: +30 2310994830
- Email: grampidi@auth.gr
Study Locations
-
-
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Thessaloníki, Greece, 54636
- Recruiting
- AHEPA University Hospital, Department of Cardiology
-
Contact:
- Georgios Rampidis, MD, MSc
- Phone Number: +306976254340
- Email: grampidi@auth.gr
-
Principal Investigator:
- Haralambos Karvounis, MD, PhD
-
Principal Investigator:
- Konstantinos Kouskouras, MD, PhD
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Principal Investigator:
- Georgios Rampidis, MD, MSc
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Principal Investigator:
- Vasileios Rafailidis, MD, PhD
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CCTA Cohort
Consecutive patients with suspected coronary artery disease and low/intermediate pre-test probability
|
128-multislice CT coronary angiography and complex atherosclerotic plaque analysis with the use of CT imaging post-processing techniques.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days
|
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
|
30 days
|
Left Anterior Descending (LAD) / Left Circumflex (LCx) bifurcation angle
Time Frame: 30 days
|
Measurement using curved MPR technique in advantage workstation server
|
30 days
|
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)
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of Coronary Atherosclerosis
Time Frame: 30 days
|
Total atherosclerotic plaque volume (mm3)
|
30 days
|
Severity of Coronary Atherosclerosis assessed by using Leiden CTA risk score
Time Frame: 30 days
|
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
|
Severity of Coronary Atherosclerosis assessed by using Gensini score
Time Frame: 30 days
|
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
|
Complexity of Coronary Artery Disease [CT-SYNTAX score]
Time Frame: 30 days
|
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
|
Frequency of occurrence of high-risk plaques
Time Frame: 30 days
|
Frequency (%) of occurrence of high-risk plaque features (HU < 30, Remodelling Index > 1.1, napkin-ring sign & spotty calcium)
|
30 days
|
Plaque burden assessment [Modified Duke CAD Index for coronary CTA]
Time Frame: 30 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Haralambos Karvounis, MD, PhD, AHEPA-Department of Cardiology
- Principal Investigator: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
December 1, 2019
First Submitted That Met QC Criteria
December 1, 2019
First Posted (Actual)
December 4, 2019
Study Record Updates
Last Update Posted (Actual)
June 5, 2020
Last Update Submitted That Met QC Criteria
June 4, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Pathological Conditions, Anatomical
- Chest Pain
- Angina Pectoris
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Atherosclerosis
- Angina, Stable
- Plaque, Atherosclerotic
Other Study ID Numbers
- GEOMETRY_29.01.2019.101068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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