Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT07293858
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography: Prognostic Value and Artificial Intelligence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between OCT-derived plaque and stent characteristics and long-term clinical outcomes', 'timeFrame': '10 years', 'description': 'Assessment of whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, stent deployment quality, and other intraluminal or vessel wall findings-are associated with long-term clinical outcomes. Outcomes include cardiac symptoms, cardiac events, coronary interventions, hospitalization, and death, based on medical records, questionnaire data, and national registries.'}], 'secondaryOutcomes': [{'measure': 'Performance of an automated OCT annotation algorithm', 'timeFrame': 'Baseline (OCT acquisition) to algorithm development period (≤5 years)', 'description': 'Evaluation of the accuracy and feasibility of an AI-based algorithm for automated annotation of OCT pullbacks. Pseudonymized OCT images will be used to train and validate automated detection of plaque features, stent characteristics, and other relevant imaging markers. Comparison will be made with expert manual annotation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optical Coherence Tomography', 'Artificial Intelligence'], 'conditions': ['Coronary Arterial Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the prognostic value of optical coherence tomography (OCT) imaging of the coronary arteries. OCT provides high-resolution images of the vessel wall and stented segments during routine cardiac catheterization. All patients who undergo OCT as part of their clinical care are invited to participate in this prospective registry.\n\nThe study will examine whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, or indicators of stent optimization-are associated with long-term clinical outcomes. Follow-up information on symptoms, medication use, hospitalizations, cardiac procedures, and major cardiac events will be collected through medical records, questionnaires, and national registry data over a period of up to 10 years.\n\nIn addition, pseudonymized OCT pullbacks will be used to support the development of an artificial intelligence (AI) algorithm for automated annotation of OCT images. This algorithm may help improve the clinical interpretation of OCT by identifying relevant imaging features in a consistent and efficient manner.\n\nParticipation is voluntary and includes permission to use clinical data, OCT images, and follow-up information for research purposes. Data are coded to protect participant privacy and stored securely according to applicable regulations. The results of this study may contribute to better understanding of coronary plaque characteristics and may support improved decision-making in interventional cardiology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of all patients who have undergone intracoronary OCT imaging of the coronary arteries as part of their routine cardiac catheterization. This is an all-comer population with no restrictions regarding indication, diagnosis, age, or comorbidities. The decision to perform OCT is made independently by the treating cardiologist. After the procedure, patients are invited to participate in this prospective registry and are included only after providing written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients undergoing intracoronary OCT imaging at the Radboud University Medical Center, and any additional centers that may join the study in the future.\n* OCT performed at the discretion of the treating physician, according to contemporary clinical guidelines.\n* Written informed consent obtained after the procedure.\n\nExclusion Criteria:\n\n* Patients who decline or are unable to provide informed consent. (Only patients who provide consent can be included.\n* Patients for whom follow-up or data collection is not feasible (e.g., no valid contact details).'}, 'identificationModule': {'nctId': 'NCT07293858', 'acronym': 'ORANGE', 'briefTitle': 'Optical Coherence Tomography: Prognostic Value and Artificial Intelligence', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Optical Coherence Tomography: Prognostic Value and Artificial Intelligence', 'orgStudyIdInfo': {'id': '2021-13271'}}, 'contactsLocationsModule': {'locations': [{'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Niels van Royen, Prof. dr.', 'role': 'CONTACT', 'email': 'niels.vanroyen@radboudumc.nl', 'phone': '+31243614533'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Joske L. van der Zande', 'role': 'CONTACT', 'email': 'joske.vanderzande@radboudumc.nl', 'phone': '0622997212', 'phoneExt': '+31611469960'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}