Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT03479593
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2017-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}, {'id': 'D000082644', 'term': 'Microvascular Density'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Correlation between operator identification of the culprit and CMR/OCT. The location of the culprit on CAG/ECG and OCT versus CMR will be evaluated by the chi2-test'}], 'secondaryOutcomes': [{'measure': 'Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'cross-tables will be used to calculate the positive predictive value Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG.'}, {'measure': 'Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Receiver-operating-characteristics will be used to compare the additional diagnostic value of OCT compared to CAG/ECG. CMR is the golden standard.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSTEMI', 'Culprit', 'Cardiac magnetic resonance', 'Optical Coherence Tomography'], 'conditions': ['NSTEMI - Non-ST Segment Elevation MI', 'Multi Vessel Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination (coronary angiogram, CAG) can be difficult.\n\nMeanwhile, identification of the culprit lesion is vital to conduct proper treatment. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled\n\nThe purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.', 'detailedDescription': 'Background\n\nAcute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. Current guidelines in NSTEMI recommend an invasive coronary angiogram (CAG) and possible treatment with percutaneous intervention (PCI) within 2-72 hours. In NSTEMI patients and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination can be difficult.\n\nMeanwhile, identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. In addition, since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI. Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled.\n\nPurpose\n\nThe overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.\n\nMethods\n\nThe study employs cardiac magnetic resonance (CMR), which allows detection of myocardium exposed to even brief periods of ischemia. Furthermore, Optical Coherence Tomography (OCT) which visualises the coronary artery lumen and wall. OCT allows for direct visualization of atherosclerotic plaques, presence of thrombus and atherosclerotic plaque ruptured that cannot be seen on a CAG alone.\n\nPatients will have CMR performed prior to CAG. The PCI operator determines culprit based on CAG and ECG changes alone. OCT is subsequently performed on culprit lesion(s) and stenosis ≥ 50%.\n\nSample size calculation\n\nAssuming the culprit lesion can be correctly identified with history/angiography/ECG in 95% of cases a positive predictive value \\>90% with 95% accuracy can be reached with 100 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible NSTEMI patients scheduled for CAG at one center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years of age\n* NSTEMI (ECG changes and/or troponin/creatine kinase myocardial band (CK-MB) rise) within 48 hours after symptom debut.\n* Multivessel disease at CAG: More than one vessel with \\>50% stenosis.\n\nExclusion Criteria:\n\n* Known intolerance of heparin or contrast medium.\n* Inability to understand information or to provide informed consent.\n* estimated glomerular filtration rate (eGFR) \\< 30 ml/min.\n* Other reasons for troponin rise not applicable to acute myocardial infarction.\n* Atrial fibrillation at admission.\n* Patients with contraindication for CMR will only have OCT performed.\n* Potential pregnancy\n* Unstable patients requiring acute CAG and PCI'}, 'identificationModule': {'nctId': 'NCT03479593', 'acronym': 'NS-CULPRIT', 'briefTitle': 'Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease', 'orgStudyIdInfo': {'id': 'H-17023377'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CMR and OCT in NSTEMI patients with MVD', 'description': 'NSTEMI patients with multi vessel disease', 'interventionNames': ['Diagnostic Test: CMR and OCT in NSTEMI patients with MVD']}], 'interventions': [{'name': 'CMR and OCT in NSTEMI patients with MVD', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lesions \\>50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography', 'armGroupLabels': ['CMR and OCT in NSTEMI patients with MVD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Kathrine Ekström, MD', 'role': 'CONTACT', 'email': 'kathrine.ekstroem.01@regionh.dk', 'phone': '+4535452295'}, {'name': 'Thomas Engstrøm, DMSCi, PhD', 'role': 'CONTACT', 'email': 'thomas.engstroem@regionh.dk', 'phone': '+4535458444'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Kathrine Ekström, MD', 'role': 'CONTACT', 'email': 'kathrine.ekstroem.01@regionh.dk', 'phone': '+4535452295'}, {'name': 'Thomas Engstrøm, DMSCi, PhD', 'role': 'CONTACT', 'email': 'thomas.engstroem@regionh.dk', 'phone': '+4535458444'}], 'overallOfficials': [{'name': 'Thomas Engstrøm, DMSCi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Thomas Engstrom', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}