Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-24 @ 4:44 PM
Study NCT ID:
NCT03129659
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2017-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2017-04-16', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of coronary CT angiography to identify patients with NSTE-ACS.', 'timeFrame': '30 day', 'description': 'Sensitivity and specificity of coronary CT angiography for the diagnosis of NSTE-ACS.'}], 'secondaryOutcomes': [{'measure': 'Potential improvement of diagnostic accuracy with FFR-CT.', 'timeFrame': '30 day', 'description': 'Off-line calculation of FFR-CT will be performed and the diagnostic accuracy for NSTE-ACS will be determined and compared to conventional coronary CT angiography.'}, {'measure': 'Clinical characteristics of no obstructive coronary artery disease on CT.', 'timeFrame': '30 day', 'description': 'To determine which clinical characteristics are predictive of not having obstructive coronary artery disease on CT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary CT Angiography', 'High-sensitivity Troponin', 'Diagnosis'], 'conditions': ['Acute Coronary Syndrome', 'Chest Pain']}, 'referencesModule': {'references': [{'pmid': '39150488', 'type': 'DERIVED', 'citation': 'Arslan M, Schaap J, van Gorsel B, Aubanell A, Budde RPJ, Hirsch A, Smulders MW, Mihl C, Damman P, Sliwicka O, Habets J, Dubois EA, Dedic A. Coronary computed tomography angiography improves assessment of patients with acute chest pain and inconclusively elevated high-sensitivity troponins. Eur Radiol. 2025 Feb;35(2):789-797. doi: 10.1007/s00330-024-10930-1. Epub 2024 Aug 16.'}, {'pmid': '34663657', 'type': 'DERIVED', 'citation': 'Arslan M, Schaap J, Van Gorsel B, Budde RP, Bekkers SC, Van Cauteren YJ, Damman P, Habets J, Dubois EA, Dedic A. Coronary CT angiography for improved assessment of patients with acute chest pain and low-range positive high-sensitivity troponins: study protocol for a prospective, observational, multicentre study (COURSE trial). BMJ Open. 2021 Oct 18;11(10):e049349. doi: 10.1136/bmjopen-2021-049349.'}]}, 'descriptionModule': {'briefSummary': 'Current evaluation of patients suspected of non-ST-elevation acute coronary syndrome is greatly dictated by the results of high-sensitivity troponins. In a substantial number of patients this approach does not provide a conclusive work-up. Patients typically present with slightly elevated high-sensitivity troponins without significant changes during serial sampling and no other clinical clues that can aid in determining the etiology of their chest pain complaints. Uncertainty remains about the optimal diagnostic management of these patients and they are often admitted to undergo invasive angiography. Coronary CT angiography can improve efficiency of clinical care in these patients by reducing unnecessary hospital admissions and invasive angiography. In this study, the investigators will investigate whether a diagnostic strategy comprising of early coronary CT angiography is more clinically efficient than standard optimal care in patients with an inconclusive work-up for non-ST-elevation acute coronary syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting to the emergency department with symptoms suggestive of NSTE-ACS. They do not fulfil criteria for either "rule-in" or "rule-out" NSTE-ACS based on serial sampling of high-sensitivity troponins and standard clinical work-up.\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent.\n* History of proven CAD, defined as documented prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft surgery.\n* Previous examination with either invasive angiography or CCTA in the last 3 years.\n* Clinical instability: clinical heart failure, hemodynamic instability, severe chest pain.\n* CCTA-specific contra-indications:\n\n * Allergy to iodine contrast media\n * Pregnancy\n * Impaired renal function: estimated glomerular filtering rate \\<60% of the age-corrected normal values\n * Severe arrhythmia likely to affect image interpretation\n * BMI \\> 40\n * Inability to cooperate during the examination.'}, 'identificationModule': {'nctId': 'NCT03129659', 'acronym': 'COURSE', 'briefTitle': 'Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome With Inconclusive Diagnostic Work-up', 'orgStudyIdInfo': {'id': 'COURSE-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-group', 'description': 'Coronary CT angiography', 'interventionNames': ['Diagnostic Test: Coronary CT Angiography']}], 'interventions': [{'name': 'Coronary CT Angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Coronary CT angiography', 'armGroupLabels': ['CT-group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Breda', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jeroen Schaap, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Amphia ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Admir Dedic, MD,PhD', 'role': 'CONTACT', 'email': 'a.dedic@erasmusmc.nl', 'phone': '0107040704'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Admir Dedic, PhD', 'role': 'CONTACT', 'email': 'a.dedic@erasmusmc.nl', 'phone': '+31107034994'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Admir Dedic', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}