An observational study in Coronary Artery Disease of Significant Bypass Graft, Coronary Syndrome and Coronary Arteriosclerosis, sponsored by Humanitas Hospital, Italy. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Humanitas Hospital, Italy · Observational
Among 34 studies in Angina, Unstable with a site in Italy — 7 open to participants now, 9 under way, none of them phase 3. Angina, Unstable · Italy.
Among the 34 studies in Angina, Unstable with a site in Italy, this one is the 8th largest by planned enrollment of the 16 observational ones that give a count, is one of 5 that started in 2023, is one of 17 observational ones, and was the 31st registered.
328 studies on the registry are indexed under Angina, Unstable; 42 are open to participants now.
Browse Angina, Unstable studies →7 of the 34 studies in Angina, Unstable with a site in Italy are open now. Recruiting first, the newest first:
Niguarda Hospital · Sites in Italy
Istituto Nazionale di Ricovero e Cura per Anziani · Sites in Italy
IRCCS Policlinico S. Donato · Sites in Italy
Catholic University of the Sacred Heart · Sites in Italy
University of Bologna · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 34 Angina, Unstable studies recruiting now, 29 (85%) set no upper age limit and 3 (9%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 5 started in 2023.
This study's planned enrollment of 1,000 is close to the median of 982 across 121 observational studies indexed under Angina, Unstable.
Median enrollment 996 across the 17 interventional studies, 1,000 across the 16 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 34 have an industry lead sponsor. The 10 most frequent:
Humanitas Hospital, Italy is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Humanitas Hospital, Italy has 1 study filed under Angina, Unstable — fewer than ten, so there is no comparison to draw.
1 of the studies in Angina, Unstable with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01218776University of BolognaInternational Survey of Acute Coronary Syndromes | 2026-12-31 |
Among the 34 studies in Angina, Unstable with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Real-world patients who underwent a last-generation CCTA and an ICA within one month from 2010 until 2023
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD.
Time frame: One month.
Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD.
Time frame: One month.
Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD
Time frame: One month.
Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD
Time frame: One month.
Started Oct 2023 (actual). Primary completion is estimated for Oct 2024, 12 months after the start.
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Humanitas Hospital, Italy