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 7, 2020
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Atherosclerosis Atherosclerotic Plaque Stable Angina||Diagnostic Test: CCTA|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|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|
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.
- 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)
- 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.
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
|Contact: Georgios P Rampidis, MD, MSc||2310994830 ext +firstname.lastname@example.org|
|AHEPA University Hospital, Department of Cardiology|
|Thessaloníki, Greece, 54636|
|Contact: Georgios Rampidis, MD, MSc +306976254340 email@example.com|
|Principal Investigator: Haralambos Karvounis, MD, PhD|
|Principal Investigator: Konstantinos Kouskouras, MD, PhD|
|Principal Investigator: Georgios Rampidis, MD, MSc|
|Principal Investigator: Vasileios Rafailidis, MD, PhD|
|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|