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Coronary Artery Geometry and the Severity of Coronary Atherosclerosis (GEOMETRY-CTA)

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ClinicalTrials.gov Identifier: NCT04185493
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Atherosclerosis Atherosclerotic Plaque Stable Angina Diagnostic Test: CCTA

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Assessment of Coronary Artery Geometry With Coronary CT Angiography: Evaluation of Atherosclerotic Plaque Burden and Composition
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CCTA Cohort
Consecutive patients with suspected coronary artery disease and low/intermediate pre-test probability
Diagnostic Test: CCTA
128-multislice CT coronary angiography and complex atherosclerotic plaque analysis with the use of CT imaging post-processing techniques.




Primary Outcome Measures :
  1. 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

  2. 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

  3. Left Anterior Descending (LAD) / Left Circumflex (LCx) bifurcation angle [ Time Frame: 30 days ]
    Measurement using curved MPR technique in advantage workstation server

  4. 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)


Secondary Outcome Measures :
  1. Extent of Coronary Atherosclerosis [ Time Frame: 30 days ]
    Total atherosclerotic plaque volume (mm3)

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185493


Contacts
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Contact: Georgios P Rampidis, MD, MSc 2310994830 ext +30 grampidi@auth.gr

Locations
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Greece
AHEPA University Hospital, Department of Cardiology
Thessaloníki, Greece, 54636
Contact: Georgios Rampidis, MD, MSc    +306976254340    grampidi@auth.gr   
Principal Investigator: Haralambos Karvounis, MD, PhD         
Principal Investigator: Konstantinos Kouskouras, MD, PhD         
Principal Investigator: Georgios Rampidis, MD, MSc         
Principal Investigator: Vasileios Rafailidis, MD, PhD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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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:

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Responsible Party: Georgios P Rampidis, MD, MSc, Academic Fellow, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04185493    
Other Study ID Numbers: GEOMETRY_29.01.2019.101068
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki:
Geometry
Bifurcation Angle
Cardiac Computed Tomography Angiography
Coronary Artery Disease
Vulnerable Coronary Plaque
Indexed Coronary Volume
Risk Assessment
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Angina, Stable
Plaque, Atherosclerotic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical