Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-06-26 @ 5:57 AM
Study NCT ID:
NCT04683133
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The FAST OCT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-12-21', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI', 'timeFrame': '0 days', 'description': 'The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI'}], 'secondaryOutcomes': [{'measure': 'The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI', 'timeFrame': '0 days', 'description': 'The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI'}, {'measure': 'The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI', 'timeFrame': '0 days', 'description': 'The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI'}, {'measure': 'Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI', 'timeFrame': '0 days', 'description': 'Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI'}, {'measure': 'Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI', 'timeFrame': '0 days', 'description': 'Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['OCT', '3D-angio-based FFR', 'Coronary Arteriosclerosis', 'NST-ACS'], 'conditions': ['Tomography, Optical Coherence', 'Myocardial Revascularization', 'NSTEMI - Non-ST Segment Elevation MI', 'Unstable Angina', 'Coronary Arteriosclerosis', '3D-angio-based FFR']}, 'descriptionModule': {'briefSummary': 'This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.', 'detailedDescription': 'Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment.\n\nPatients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation.\n\nThe primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Presenting with NST-ACS\n* At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online QCA)\n* Target vessel with a reference vessel diameter (RVD) ≥2.5 and ≤ 5.0 mm as assessed by QCA or visual estimation\n* The patient is willing to participate in the study\n* Target vessel suitable for OCT imaging\n\nExclusion Criteria:\n\n* Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow \\<3\n* Target lesion located within 5.0 mm of vessel origin\n* Severe tortuosity\n* Chronic total occlusion of the target vessel\n* Target lesion is located in or supplied by an arterial or venous bypass graft.\n* Impaired renal function (eGFR \\<30ml/min) \\*\n* Pregnant or breastfeeding patients \\*\n* Patient has a known allergy to contrast medium \\*\n* Contraindication for the use of nitrates \\*\n* Life expectancy \\<12 months'}, 'identificationModule': {'nctId': 'NCT04683133', 'briefTitle': 'The FAST OCT Study', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study', 'orgStudyIdInfo': {'id': 'The FAST OCT study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm', 'description': 'Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.', 'interventionNames': ['Diagnostic Test: Optical coherence tomography assessment']}], 'interventions': [{'name': 'Optical coherence tomography assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joost Daemen, MD;PhD', 'role': 'CONTACT', 'email': 'j.daemen@erasmusmc.nl', 'phone': '+31 10 703 5260'}, {'name': 'Maria Natalia Tovar Forero, MD', 'role': 'CONTACT', 'email': 'm.tovarforero@erasmusmc.nl', 'phone': '+31 10 703 8896'}, {'name': 'Joost Daemen, MD;PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maria Natalia Tovar Forero, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}, {'name': 'Pie Medical Imaging', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interventional Cardiologist', 'investigatorFullName': 'Joost Daemen', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}