Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 6:14 AM
Study NCT ID:
NCT05508893
Status:
TERMINATED
Last Update Posted:
2022-08-26
First Post:
2022-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Every participant will perform an exercise test and receive a CTA afterwards'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'whyStopped': 'Funding stopped', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-18', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool', 'timeFrame': '8 Years'}], 'secondaryOutcomes': [{'measure': 'Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA', 'timeFrame': '8 Years', 'description': 'Both modalities are used to track down clinically relevant CAD. Clinically relevant CAD is defined as a stenosis of \\>50%.'}, {'measure': 'Compare the incidence of Major Adverse Cardiac Events (MACE) and all-cause mortality in populations screened between primary and secondary screening after 12 months', 'timeFrame': '8 Years'}, {'measure': 'Compare the incidence of coronary angiograms and revascularization procedures in the population screened with CTA compared to a historical population using CTA as a secondary screening tool', 'timeFrame': '8 Years'}, {'measure': 'Establish the additive value of coronary artery calcium score (CACS) in addition to clinical risk scores as a predictor of CAD on CCTA', 'timeFrame': '8 Years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease (CAD)', 'Coronary Artery Calcification', 'Occupational Diseases', "Aviator's; Disease"]}, 'referencesModule': {'references': [{'pmid': '40550709', 'type': 'DERIVED', 'citation': 'Frijters E, Nathoe H, Grobben R, Broekhuizen L, Rienks R, Velthuis B. Prevalence and severity of coronary artery disease in asymptomatic military air crew in the Netherlands: a prospective, cross-sectional study (SUSPECT). BMJ Open. 2025 Jun 23;15(6):e100250. doi: 10.1136/bmjopen-2025-100250.'}]}, 'descriptionModule': {'briefSummary': 'SUSPECT is a prospective, single-center, cohort study of 250 military aircrew at the Center for Man in Aviation, Royal Netherlands Air Force. All asymptomatic aircrew (≥40 years) are asked to undergo a coronary CT scan on a voluntary basis, following the exercise electrocardiograms performed at their routine aeromedical examination. Coronary Artery Calcium score (CACS) and CCTA findings are reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Military aircrew of the Royal Netherlands Air Force\n* ≥ 40 years old\n* Required to undergo cardiac screening (per military aviation regulations)\n\nExclusion Criteria:\n\n* Typical angina\n* Prior myocardial infarction\n* Prior revascularization therapy (i.e. percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG))\n* Left ventricular ejection fraction \\<35%\n* Does not comprehend study requirements, and/or is unwilling or unable to comply to study procedures\n* CT-related contra-indications\n\n * Allergic to iodine contrast.\n * Renal insufficiency (GFR \\<60 ml/min/1.73m2, calculated with the Modification of Diet in Renal Disease (MDRD) calculator: http://nephron.org/mdrd\\_gfr\\_si.\n * Severe claustrophobia.\n * Uncontrolled irregular heart rhythm or tachycardia unresponsive to beta blockade\n * Pregnancy'}, 'identificationModule': {'nctId': 'NCT05508893', 'acronym': 'SUSPECT', 'briefTitle': 'Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)', 'orgStudyIdInfo': {'id': '13-693/D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CT Angiography', 'description': 'Coronary CT Angiography will be performed on all individuals', 'interventionNames': ['Radiation: CT Angiography']}, {'type': 'OTHER', 'label': 'Exercise stress test', 'description': 'An bicycle exercise stress test will be performed on all individuals', 'interventionNames': ['Diagnostic Test: Exercise stress test']}], 'interventions': [{'name': 'CT Angiography', 'type': 'RADIATION', 'description': 'A CTA will be performed on asymptomatic individuals', 'armGroupLabels': ['CT Angiography']}, {'name': 'Exercise stress test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A routine exercise stress test will be performed on a bicycle', 'armGroupLabels': ['Exercise stress test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3769 DE', 'city': 'Soesterberg', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'Center for Man in Aviation', 'geoPoint': {'lat': 52.11833, 'lon': 5.28611}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht University Medical Center', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Hendrik Nathoe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}, {'name': 'Erik Frijters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Man in Aviation, Royal Netherlands Air Force', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erik Frijters', 'investigatorAffiliation': 'UMC Utrecht'}}}}