Clinical trial NCT06273033: Implementation of Contemporary Coronary CT Angiography in Clinical Practice
Official title: Implementation of Contemporary Coronary CT Angiography in Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease of Significant Bypass Graft
Coronary Syndrome
Coronary Arteriosclerosis
Keywords: Coronary Artery Disease
Coronary Computed Tomography Angiography
Invasive Coronary Angiography
Lead sponsor: Humanitas Hospital, Italy
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Real-world patients who underwent a last-generation CCTA and an ICA within one month from 2010 until 2023

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* CCTA with \>64 rows
* ICA performed within one month from CCTA

Exclusion Criteria:

- age\<18 years

Primary outcomes:
measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD.
timeFrame: One month.
Secondary outcomes:
measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD.
timeFrame: One month.
measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD
timeFrame: One month.
measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD
timeFrame: One month.
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: Milano
Study officials:
affiliation: IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy
name: Giulio Stefanini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy
name: Marco Francone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy
name: Carlo Andrea Pivato, MD
role: PRINCIPAL_INVESTIGATOR
References: