Implementation of Contemporary Coronary CT Angiography in Clinical Practice

NCT ID: NCT06273033

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2025-01-31

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.

Conditions

Coronary Artery Disease of Significant Bypass Graft; Coronary Syndrome; Coronary Arteriosclerosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients who have undergone last-generation CCTA and ICA.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• CCTA with >64 rows
• ICA performed within one month from CCTA

Exclusion Criteria

• age<18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Humanitas Hospital, Italy

OTHER

Sponsor Role: lead

Responsible Party

Giulio Stefanini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giulio Stefanini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy

Marco Francone, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy

Carlo Andrea Pivato, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy

Locations

IRCCS Humanitas Research Hospital

Rozzano, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carlo Andrea Pivato, MD

Role: CONTACT

carlo.pivato@humanitas.it

+39 02 8224 7235

Facility Contacts

Carlo Andrea Pivato, MD

Role: primary

carlo.pivato@humanitas.it

+39 02 8224 7235

Other Identifiers

CONCORDE

Identifier Type: -

Identifier Source: org_study_id