Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06273033 |
| Other study ID # |
CONCORDE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 10, 2023 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Humanitas Hospital, Italy |
| Contact |
Carlo Andrea Pivato, MD |
| Phone |
+39 02 8224 7235 |
| Email |
carlo.pivato[@]humanitas.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most
patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary
angiography. It is therefore pivotal to understand instances of discrepancies that are
encountered in clinical practice. Moreover, most of the literature on this topic relies on
obsolete machines or definitions of coronary artery stenosis that cannot be defined as
severe.
The investigators aim 1) to report the real word data on the performance of last-generation
CCTA in identifying obstructive coronary artery disease (also considering different
thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of
discrepancies.
Description:
Most updated international guidelines recommend Coronary Computed Tomography Angiography
(CCTA) as the initial test to rule out coronary artery disease (CAD). CCTA should also be
considered an alternative to invasive coronary angiography (ICA) for non-diagnostic or
indeterminate results of other noninvasive tests. Thanks to spatial and temporal resolution
increase, CCTA is now considered in an extensive range of pre-test probability (PTP), from 5%
to 90%. Indeed, the accuracy of CCTA for identifying patients with at least one significant
coronary arterial stenosis, defined as moderate (≥50%) by ICA, has reached almost 90%.
Furthermore, CCTA and anatomical evaluation seem superior to stress testing for risk
prediction among patients with at least moderate ischemia. As a result, CCTA has been
recognized as the first-line diagnostic test for most patients with suspected chronic
coronary syndrome and even in some acute chest pain presentation.
Suppose CCTA serves as a gatekeeper for ICA because of its high negative predictive value and
eventually will replace ICA in its diagnostic role, as hypothesized. In that case, it is
pivotal to understand instances of discrepancies that are encountered in clinical practice.
In addition, prior studies have primarily evaluated the performance of CCTA in identifying a
≥moderate coronary stenosis (i.e., ≥50% lumen narrowing) as compared with ICA. Instead, there
is much less evidence of its ability to rule out severe coronary stenosis (i.e., ≥70% lumen
narrowing). This is noteworthy because recent studies have shown that the anatomic severity
of CAD has a strong prognostic impact, even more than ischemia. Finally, new techniques such
as dynamic stress CT perfusion (stress-CTP) and fractional flow reserve CT derived (FFR-CT)
emerged as potential strategies to combine anatomical and functional evaluation providing
additional diagnostic accuracy.
Against this background, the investigators aim 1) to report the real word data on the
performance of last-generation CCTA in identifying obstructive CAD (also considering
different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of
discrepancies. The investigators hope this study will help interpret CCTA findings in
clinical practice and eventually refine the diagnostic algorithm for patients with
obstructive CAD.
