Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 1:16 PM
Study NCT ID:
NCT05169333
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2021-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oxford Risk Factors And Non-Invasive Imaging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250000}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac and all cause mortality', 'timeFrame': '15 years', 'description': 'Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict future cardiac and all-cause mortality over a period of 15 years post CT scan.'}, {'measure': 'Non-fatal vascular events', 'timeFrame': '15 years', 'description': 'Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict future non-fatal vascular events over a period of 15 years post CT scan.'}, {'measure': 'Cardiac and non-cardiac findings by Computed Tomography', 'timeFrame': '15 years', 'description': 'Using novel image analysis methods, clinical risk factors, and blood biomarkers to detect pathology from Computed Tomography images.'}, {'measure': 'Progression of disease', 'timeFrame': '15 years', 'description': 'Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict progression of cardiometabolic diseases over a period of 15 years post index CT scan.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular risk factors', 'timeFrame': '15 years', 'description': 'Using novel image analysis methods and blood biomarkers, to detect and monitor cardiovascular risk factors and responsiveness to routine clinical care'}, {'measure': 'Hospital admissions for any reason classified using ICD10', 'timeFrame': '15 years', 'description': 'Using novel image analysis methods, to predict hospital admissions over a period of 15 years post CT scan'}, {'measure': 'Genotyping', 'timeFrame': '15 years', 'description': 'Using genotyping to predict clinical phenotypes'}, {'measure': 'Progression of cardiovascular disease', 'timeFrame': '15 years', 'description': 'Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict disease progression measured by CT scans'}, {'measure': 'Validation and refinement of the CaRi Image analysis platform', 'timeFrame': '15 years', 'description': 'Validate the prognostic and diagnostic performance of CaRi Image analysis platform against the other study outcomes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Cardiovascular Risk Factors']}, 'referencesModule': {'references': [{'pmid': '39023142', 'type': 'DERIVED', 'citation': 'Westwood M, Armstrong N, Krijkamp E, Perry M, Noake C, Tsiachristas A, Corro-Ramos I. A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model. Health Technol Assess. 2024 Jul;28(31):1-105. doi: 10.3310/WYGC4096.'}]}, 'descriptionModule': {'briefSummary': 'ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.', 'detailedDescription': 'The ORFAN registry will include unselected, consecutive patients undergoing CT scans (coronary CT angiograms (CCTA), CT chest, abdomen and pelvis scans) collected at the participating centres. The study will combine imaging data with patient demographics and clinical information (including prospective outcomes) to aid the development and/or validation of new or existing image analysis algorithms and software tools to improve diagnosis, clinical risk discrimination and prediction. Specifically, ORFAN will evaluate the specificity, utility and predictive value of newly developed image analysis methods. ORFAN will recruit and follow-up patients prospectively, linking the index CT scan with blood biomarkers, genetic information as well as information on disease progression (recorded through follow-up CT scans) and clinical outcomes data.\n\nThe study will also collect CT scans performed in the past and link them with clinical factors and prospective outcomes data collected after the index scan was performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from secondary and tertiary NHS care providers in the UK and from international sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria for study Arms 1, 2 and 3:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged 18 -99 years.\n\nInclusion Criteria for study Arm 4:\n\n• Male or Female, aged 18 -99 years.\n\nExclusion Criteria:\n\nExclusion Criteria for Study Arms 1, 2 and 3:\n\n* Unable or unwilling to consent\n* Active cancer\n\nExclusion Criteria for Study Arm 4:\n\n* Participation in Study Arms 1, 2 or 3\n* Existing opt-out from use of data for research purposes'}, 'identificationModule': {'nctId': 'NCT05169333', 'acronym': 'ORFAN', 'briefTitle': 'The Oxford Risk Factors And Non-Invasive Imaging Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'The Oxford Risk Factors And Non-Invasive Imaging Study', 'orgStudyIdInfo': {'id': 'The ORFAN Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Participants attending cardiology department, hypertension or outpatient clinics.'}, {'label': 'Group 2', 'description': 'Participants who are recruited prospectively, during their clinically indicated CT scan, and they are followed-up prospectively for clinical endpoints; A follow-up CCTA at least 6 months later will be offered to a subgroup of these patients, to assess disease progression.'}, {'label': 'Group 3', 'description': 'Individuals where at least 6 months have elapsed from previous CCTA will undergo repeat CCTA scan and enter prospective follow up for clinical endpoints.'}, {'label': 'Group 4', 'description': 'Cohort of consecutive patients who have undergone clinical CTAs or unenhanced CT chest, abdomen and pelvis in the past, linking the index CT scan with prospective outcomes collection already accumulated.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NIH National Heart, Lunch, and Blood Institute', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Rochester', 'state': 'Minnesota', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic Heart and Vascular Institute', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Adelaide', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Flinders University', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Sydney', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'The University of Sydney', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Leuven', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'TEDA International Cardiovascular Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Aix-en-Provence', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': 'Almaviva Sante - Clinique Axium', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Friedrich-Alexander-Universitat Erlangen-Nurmberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Ulm', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'University Hospital Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'Lefkos Stavros Clinic', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'MTA-SE Cardiovascular Imaging Research Group', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino IRCCS, University of Milan', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Ōita', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Oita University', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Amsterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Amsterdam Universitair Medische Centra', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Sittard', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Zuyderland Medical Centre', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}, {'city': 'Târgu Mureş', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'University of Medicine and Pharmacy of Targu Mures', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Abu Dhabi', 'status': 'NOT_YET_RECRUITING', 'country': 'United Arab Emirates', 'facility': 'Cleveland Clinic Abu Dhabi', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'city': 'Bath', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal United Hospitals Bath NHS Foundation Trust', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Sandwell and West Birmingham Hospitals NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Birmingham', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Papworth Hospital NHS Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Edinburgh', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'University of Edinburgh, Royal Infirmary', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Glasgow', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'NHS Greater Glasgow and Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Leicester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'University Hosptials of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Liverpool', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Brompton and Harefield Hospitals', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'facility': 'University Hospital of Manchester NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Milton Keynes', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Milton Keynes University Hospital', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}, {'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Wolverhampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Heart and Lung Centre, New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'centralContacts': [{'name': 'Kenneth Chan', 'role': 'CONTACT', 'email': 'kenneth.chan@cardiov.ox.ac.uk'}, {'name': 'Charalambos Antoniades', 'role': 'CONTACT', 'email': 'charalambos.antoniades@cardiov.ox.ac.uk'}], 'overallOfficials': [{'name': 'Antoniades', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Caristo Diagnostics Limited', 'class': 'INDUSTRY'}, {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'British Heart Foundation', 'class': 'OTHER'}, {'name': 'Innovate UK', 'class': 'OTHER_GOV'}, {'name': 'European Commission', 'class': 'OTHER'}, {'name': 'National Consortium of Intelligent Medical Imaging', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}