Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-01 @ 3:22 PM
Study NCT ID:
NCT05007535
Status:
UNKNOWN
Last Update Posted:
2023-01-18
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D013927', 'term': 'Thrombosis'}], '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'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '12 Months', 'description': 'A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization'}, {'measure': 'IVUS-guided optimization', 'timeFrame': 'Procedural', 'description': 'Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI'}], 'secondaryOutcomes': [{'measure': 'TVF', 'timeFrame': '30 Days', 'description': 'A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization'}, {'measure': 'Major Adverse Cardiovascular Events (MACE)', 'timeFrame': '30 Days', 'description': 'A composite of all-cause mortality, any myocardial infarction and repeat revascularization'}, {'measure': 'Major Adverse Cardiovascular Events (MACE)', 'timeFrame': '12 Months', 'description': 'A composite of all-cause mortality, any myocardial infarction and repeat revascularization'}, {'measure': 'Individual Components of TVF and MACE', 'timeFrame': '30 Days', 'description': 'Individual components of the composite endpoints'}, {'measure': 'Individual Components of TVF and MACE', 'timeFrame': '12 months', 'description': 'Individual components of the composite endpoints'}, {'measure': 'Major Intraprocedural Complications', 'timeFrame': 'Procedural', 'description': 'Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (\\> 2 mm)'}, {'measure': 'Angiographic Endpoints', 'timeFrame': 'Procedural', 'description': 'Including final TIMI flow and final myocardial blush grade'}, {'measure': 'IVUS endpoints (continuous)', 'timeFrame': 'Procedural', 'description': 'At least the following continuous variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks:\n\n* Minimal lumen area\n* Thrombus containing frames\n* Thrombus maximum angle\n* Minimal stent area\n\nStructured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software.'}, {'measure': 'IVUS endpoints (categorical)', 'timeFrame': 'Procedural', 'description': 'At least the following categorical variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks:\n\n* Plaque rupture\n* Convex calcium (nodule)\n* Thrombus type\n* Plaque type\n* Thrombus protrusion\n* Underexpansion\n* Edge dissection\n* Hematoma\n* High plaque burden at stent edges\n* Residual focal lesion\n* Malapposition\n\nStructured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Invasive Coronary Imaging'], 'conditions': ['ST Elevation Myocardial Infarction', 'Acute Myocardial Infarction', 'Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Intravascular Ultrasound', 'Thrombus']}, 'referencesModule': {'references': [{'pmid': '37232425', 'type': 'DERIVED', 'citation': 'Groenland FTW, Ziedses des Plantes AC, Neleman T, Scoccia A, Ligthart JMR, Witberg KT, Mahmoud KD, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Van Mieghem NM, Daemen J. Culprit lesion plaque characterization and thrombus grading by high-definition intravascular ultrasound in patients with ST-segment elevation myocardial infarction. Catheter Cardiovasc Interv. 2023 Aug;102(2):191-199. doi: 10.1002/ccd.30699. Epub 2023 May 26.'}, {'pmid': '35437257', 'type': 'DERIVED', 'citation': 'Groenland FTW, Mahmoud KD, Neleman T, Ziedses des Plantes AC, Scoccia A, Ligthart J, Witberg KT, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Kardys I, Cummins P, Van Mieghem NM, Daemen J. Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. Open Heart. 2022 Apr;9(1):e001955. doi: 10.1136/openhrt-2021-001955.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with ST-elevation myocardial infarction (STEMI).\n\nObjectives:\n\n* To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.\n* To assess IVUS-guided optimization in STEMI patients.\n* To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.\n* To assess and quantify thrombus in STEMI patients with HD-IVUS.\n* To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.', 'detailedDescription': 'The SPECTRUM study is an investigator-initiated, single-center, prospective, single arm, observational cohort study investigating the safety and efficacy of (HD)-IVUS as guidance for primary PCI in 200 patients with STEMI. This study enables the assessment of culprit lesion plaque characteristics and thrombus morphology with a 40-60 MHz HD-IVUS catheter.\n\nAll study patients will have a protocolized pre-intervention IVUS pullback directly after recanalization (so before any lesion preparation, i.e. balloon dilatation, aspiration thrombectomy or stent placement) and a post-intervention IVUS pullback. Subsequently, if IVUS-guided optimization is performed, a final pullback is highly recommended and considered as the post-optimization IVUS pullback.\n\nThe primary study outcomes are target vessel failure at 12 months and incidence of IVUS-guided optimization. More information on outcome measures is provided in the section below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with ST-elevation myocardial infarction eligible for primary percutaneous coronary intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Native coronary artery culprit lesion, angiographically\n* Culprit vessel reference diameter ≥ 2.25 mm, angiographically\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Presentation \\> 12 hours after symptom onset'}, 'identificationModule': {'nctId': 'NCT05007535', 'acronym': 'SPECTRUM', 'briefTitle': 'Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound', 'orgStudyIdInfo': {'id': 'SPECTRUM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HD-IVUS-guided primary PCI', 'description': 'Prospective, single arm, observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Joost Daemen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acist Medical Systems', 'class': 'INDUSTRY'}, {'name': 'MicroPort CRM', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joost Daemen', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}