Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT06273033
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of Contemporary Coronary CT Angiography in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD.', 'timeFrame': 'One month.'}], 'secondaryOutcomes': [{'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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Coronary Computed Tomography Angiography', 'Invasive Coronary Angiography'], 'conditions': ['Coronary Artery Disease of Significant Bypass Graft', 'Coronary Syndrome', 'Coronary Arteriosclerosis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nSuppose 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.\n\nAgainst 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Real-world patients who underwent a last-generation CCTA and an ICA within one month from 2010 until 2023', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CCTA with \\>64 rows\n* ICA performed within one month from CCTA\n\nExclusion Criteria:\n\n\\- age\\<18 years'}, 'identificationModule': {'nctId': 'NCT06273033', 'acronym': 'CONCORDE', 'briefTitle': 'Implementation of Contemporary Coronary CT Angiography in Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Hospital, Italy'}, 'officialTitle': 'Implementation of Contemporary Coronary CT Angiography in Clinical Practice', 'orgStudyIdInfo': {'id': 'CONCORDE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who have undergone last-generation CCTA and ICA.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Andrea Pivato, MD', 'role': 'CONTACT', 'email': 'carlo.pivato@humanitas.it', 'phone': '+39 02 8224 7235'}], 'facility': 'IRCCS Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Carlo Andrea Pivato, MD', 'role': 'CONTACT', 'email': 'carlo.pivato@humanitas.it', 'phone': '+39 02 8224 7235'}], 'overallOfficials': [{'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', 'affiliation': 'IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Hospital, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giulio Stefanini', 'investigatorAffiliation': 'Humanitas Hospital, Italy'}}}}