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Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured fractional flow reserve (FFR) is currently used for ruling out significant coronary artery disease. FFRCT is a novel non-invasive technique in which FFR is derived from CT images, however this method is currently, just like CCTA, lacking specificity. Spectral Detector CT (SDCT) is a novel technique whereby a spectrum of monoenergetic images at different kiloelectron Volt (keV) values (40 to 200 keV) can be reconstructed. By using these monoenergetic images, a decrease in blooming and beam-hardening artifacts could be achieved. In addition, SDCT offers the opportunity to assess myocardial iodine distribution and quantification. When combining these factors, we hypothesize more accurate information will be available about the coronary anatomy, degree of stenosis and FFRCT and thereby contribute to a more accurate way for the detection of hemodynamic significant stenosis. Therefore, the aim of this study is to assess the accuracy of SDCT as a non-invasive way for the detection of hemodynamically significant coronary artery stenosis.
Objective: The overall objective of this project is to assess the accuracy of SDCT for the detection of flow limiting stenosis in the coronary arteries using invasive FFR as the standard of reference. Whereby different sub-aims (e.g. improvement of FFRCT) are made to answer the overall objective. The secondary objective is to determine the decrease of calcium blooming of calcifications and beam-hardening artifacts and the improvement of myocardial blood volume quantification on SDCT in comparison with conventional CT.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-layer spectral detector CT | Device | A dual energy CT approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow limiting stenosis in the coronary arteries defined by invasive fractional flow reserve (FFR) | An invasive FFR <0.8 indicates a flow limiting stenosis | within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Participants ≥18 years of age with suspected or known stable angina with pre-test likelihood of 50-85% for obstructive coronary disease (Eur Heart J 2013 guidelines on stable CAD) and who are referred for clinical invasive FFR.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robbert van Hamersvelt, MD | Contact | +31887550441 | R.W.vanHamersvelt-3@umcutrecht.nl | |
| Tim Leiner, MD, PhD | Contact | +31887556687 | T.Leiner@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Tim Leiner, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center UtrechtU | Recruiting | Utrecht | 3508GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30826767 | Derived | van Hamersvelt RW, Isgum I, de Jong PA, Cramer MJM, Leenders GEH, Willemink MJ, Voskuil M, Leiner T. Application of speCtraL computed tomogrAphy to impRove specIficity of cardiac compuTed tomographY (CLARITY study): rationale and design. BMJ Open. 2019 Mar 1;9(3):e025793. doi: 10.1136/bmjopen-2018-025793. |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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