Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-04-08 @ 6:53 PM
Study NCT ID:
NCT06387693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence in ANOCA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of myocardial ischemia in patients with equivocal coronary function test results', 'timeFrame': 'During the procedure', 'description': 'The prevalence of ischemic changes on the intracoronary ECG in patients with equivocal coronary function test results.'}, {'measure': 'Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders', 'timeFrame': 'During the procedure', 'description': 'Accuracy of the Holter ECG to identify ischemic ECG changes compared with the standard 12-lead ECG during acetylcholine-provoked chest pain.'}, {'measure': 'Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders', 'timeFrame': '7 days', 'description': 'Diagnostic accuracy of outpatient Holter monitoring to diagnose vasomotor disorders using the coronary function test results as the reference standard'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Angina, Stable']}, 'descriptionModule': {'briefSummary': 'Angina pectoris is diagnosed in \\>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.\n\nThe origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.\n\nDuring CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical indication for comprehensive coronary function testing because of persisting chest discomfort at least 2 times per week despite current medical therapy.\n2. Absence of obstructive coronary artery disease with an indication for revascularization, documented by means of recent coronary computed tomography angiography (CCTA) or invasive coronary angiography (with invasive coronary pressure measurements if clinically indicated).\n3. Patient is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Absence of chest discomfort after initiation of medical therapy.\n2. Language barrier preventing sufficient understanding and communication in Dutch.'}, 'identificationModule': {'nctId': 'NCT06387693', 'acronym': '(AI)NOCA', 'briefTitle': 'Artificial Intelligence in ANOCA', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Artificial Intelligence-assisted Diagnostics In Angina With No Obstructive Coronary Artery Disease', 'orgStudyIdInfo': {'id': '24U-1359'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Holter monitoring, intracoronary ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Holter monitoring device to track ECG abnormalities during spontaneous chest pain in the outpatient setting. Intracoronary ECG to evaluate perprocedural ECG responses'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tim P van de Hoef, MD, PhD', 'role': 'CONTACT', 'email': 't.p.vandehoef@umcutrecht.nl', 'phone': '+3188755555'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'A fully anonymized data set containing data from those patients who agreed with data sharing will be available upon reasonable request 12 months after finalization of the study.', 'ipdSharing': 'YES', 'description': 'IPD will be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tim P. van de Hoef', 'investigatorAffiliation': 'UMC Utrecht'}}}}