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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 1, 2019
First Posted Date December 4, 2019
Last Update Posted Date January 28, 2020
Estimated Study Start Date March 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2019)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 3, 2019)
  • Extent of Coronary Atherosclerosis [ Time Frame: 30 days ]
    Total atherosclerotic plaque volume (mm3)
  • 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.
  • 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.
  • 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.
  • 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)
  • 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.
Original Secondary Outcome Measures
 (submitted: December 1, 2019)
  • Extent of Coronary Atherosclerosis [ Time Frame: 30 days ]
    Total atherosclerotic plaque volume (mm3)
  • Severity of Coronary Atherosclerosis with Leiden CTA risk score [ Time Frame: 30 days ]
    Leiden CTA risk score
  • Severity of Coronary Atherosclerosis with Gensini score [ Time Frame: 30 days ]
    Gensini score
  • Complexity of Coronary Artery Disease [ Time Frame: 30 days ]
    CT-SYNTAX score
  • 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)
  • Plaque burden assessment [ Time Frame: 30 days ]
    Modified Duke CAD Index for coronary CTA
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Coronary Artery Geometry and the Severity of Coronary Atherosclerosis
Official Title Assessment of Coronary Artery Geometry With Coronary CT Angiography: Evaluation of Atherosclerotic Plaque Burden and Composition
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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
Condition
  • Coronary Artery Disease
  • Atherosclerosis
  • Atherosclerotic Plaque
  • 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.
Study Groups/Cohorts CCTA Cohort
Consecutive patients with suspected coronary artery disease and low/intermediate pre-test probability
Intervention: Diagnostic Test: CCTA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 1, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Georgios P Rampidis, MD, MSc 2310994830 ext +30 grampidi@auth.gr
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT04185493
Other Study ID Numbers GEOMETRY_29.01.2019.101068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki
Study Sponsor Aristotle University Of Thessaloniki
Collaborators Not Provided
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
PRS Account Aristotle University Of Thessaloniki
Verification Date January 2020