Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 1:44 PM
Study NCT ID:
NCT00330928
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2006-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SPECTACL: SPECTroscopic Assessment of Coronary Lipid
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pshah@infraredx.com', 'phone': '781-221-0053', 'title': 'Director Clinical and Regulatory', 'organization': 'InfraReDx, Inc'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Technical limits of the prototype device factored into the data set reduction(28 patients).Data made available to evaluate handling of the device(30 patients) could not be prospectively evaluated for the primary endpoint of Spectral Similarity.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intravascular Coronary Imaging', 'description': 'Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging', 'otherNumAffected': 20, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Chest Pain/Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 28, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral Vascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Spectral Similarity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravascular Coronary Imaging', 'description': 'Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '93'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was \\>=67%, on a continuous range of 0%(different) to 100%(identical) similarity.', 'unitOfMeasure': 'percent similarity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '58 Subjects were excluded from endpoint analysis for No NIRS data(17), Inadequate data per protocol(11), and Data Accessible during comparison set generation(30).A similarity success was met if \\>80% of the NIRS data for a subject was similar to the autopsy NIRS set.', 'anticipatedPostingDate': '2009-01'}, {'type': 'SECONDARY', 'title': 'Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes', 'timeFrame': 'Baseline', 'description': 'This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics', 'timeFrame': 'Baseline', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravascular Coronary Imaging', 'description': 'Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging'}], 'classes': [{'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Target Vessel Revascularization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cerebral Vascular Accident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 7 day', 'description': 'Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that were enrolled, intent to treat population, were evaluated for definite or probable relation to the investigational device. This includes 7 subjects that were not exposed to the investigational device.'}, {'type': 'SECONDARY', 'title': 'Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.', 'timeFrame': '1 year', 'description': 'Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravascular Coronary Imaging', 'description': 'Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects that signed consent and were subject to research procedures.', 'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': '7 Day Phone Contact', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': '1 Year Phone Contact', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'IVUS could not be performed.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Subjects were recruited from patients presenting to the cardiac catheterization laboratory for scheduled elective percutaneous coronary intervention. Subject's medical history and angiographic coronary anatomy were used to evaluate eligibility."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravascular Coronary Imaging', 'description': 'Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.67', 'spread': '9.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2006-05-26', 'resultsFirstSubmitDate': '2009-01-28', 'studyFirstSubmitQcDate': '2006-05-26', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-06', 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spectral Similarity', 'timeFrame': 'Baseline', 'description': 'Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was \\>=67%, on a continuous range of 0%(different) to 100%(identical) similarity.'}], 'secondaryOutcomes': [{'measure': 'Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes', 'timeFrame': 'Baseline', 'description': 'This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.'}, {'measure': 'Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics', 'timeFrame': 'Baseline'}, {'measure': 'Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment', 'timeFrame': 'Baseline to 7 day', 'description': 'Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.'}, {'measure': 'Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.', 'timeFrame': '1 year', 'description': 'Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Angina Pectoris', 'Angina, Unstable', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '19608137', 'type': 'RESULT', 'citation': "Waxman S, Dixon SR, L'Allier P, Moses JW, Petersen JL, Cutlip D, Tardif JC, Nesto RW, Muller JE, Hendricks MJ, Sum ST, Gardner CM, Goldstein JA, Stone GW, Krucoff MW. In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study. JACC Cardiovasc Imaging. 2009 Jul;2(7):858-68. doi: 10.1016/j.jcmg.2009.05.001."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention (PCI).', 'detailedDescription': 'Extensive studies conducted over the past 7 years in autopsy specimens have demonstrated that NIR spectroscopy can identify the plaque structures that are suspected to cause the acute coronary artery syndromes(unstable angina, myocardial infarction, and sudden death).\n\nThe application of NIR spectroscopy to identify lipid deposition within coronary arteries has shown promising results in preclinical ex vivo studies (14). Infrared spectra are collected as follows: light of discrete wavelengths from a laser is directed onto the tissue sample via glass fibers. Light scattered from the samples is collected in fibers and launched into a spectrometer. The plot of signal intensity as a function of wavelength can be then used to develop chemometric models to discriminate lipid-rich deposits from non-atherosclerotic tissue, and from atherosclerotic tissue that is predominantly fibrotic and from blood elements. This technique is incorporated into a thin catheter with similar dimensions to an IVUS catheter, and the intracoronary dwell time for analysis is similar to the broad experience with established techniques with proven safety, such as IVUS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>=18yrs and undergoing elective or non-emergent PCI of a de novo native coronary artery lesion\n* Treatment plan (at time of consent and at time of intervention) must be to perform an intervention on no more than 2 lesions, where one is the culprit lesion and the other lesion requires revascularization at the discretion of the treating physician.\n* Target lesion should have "low-risk" characteristics(defined by angiography)\n* Subject must be able to read, understand and sign an approved informed consent form and follow protocol\n* Female subjects of child bearing potential must have a negative serum pregnancy test prior to enrollment\n\nExclusion Criteria:\n\n* Evidence of Clinical instability in the 6 hours before the procedure, or at any time during the procedure (72 hours stable post-STEMI)\n* Angiographically Unsuitable Coronary and/or Lesion Morphology in the culprit vessel.\n* A contraindication to anticoagulation or increased risk of bleeding.\n* Clinically significant abnormal laboratory findings\n* Presence of a drug eluting stent in the artery for experimental study prior to NIR measurement, unless all struts are covered by endothelium as documented by IVUS\n* Elective PCI on or through bypass grafts or LIMA grafts\n* Allergy or intolerance to aspirin or clopidogrel\n* Planned use of laser ablation, rotational ablation, brachytherapy, or atherectomy device\n* Enrollment or participation in any other medication trial within the previous 30 days\n* Current enrollment participation or enrolled in another clinical trial\n* Any other factor that the investigator feels would put the patient at increased risk if participating in the protocol'}, 'identificationModule': {'nctId': 'NCT00330928', 'acronym': 'SPECTACL', 'briefTitle': 'SPECTACL: SPECTroscopic Assessment of Coronary Lipid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infraredx'}, 'officialTitle': 'Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': '0101'}, 'secondaryIdInfos': [{'id': 'CL0101'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Subjects undergoing elective percutaneous coronary intervention', 'interventionNames': ['Device: Near Infrared Spectroscopy (NIRS) Imaging', 'Device: intravascular ultrasound (IVUS)']}], 'interventions': [{'name': 'Near Infrared Spectroscopy (NIRS) Imaging', 'type': 'DEVICE', 'otherNames': ['InfraReDx, LipiScan (prototype)'], 'description': 'Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.', 'armGroupLabels': ['1']}, {'name': 'intravascular ultrasound (IVUS)', 'type': 'DEVICE', 'otherNames': ['Volcano, Revolution', 'Volcano, Eagle Eye', 'Boston Scientific, Atlantis'], 'description': 'Ultrasound coronary catheter is positioned on a guidewire that has been placed in the coronary artery.Ultrasound imaging provides structural information about the vessel wall and blockages contained. It takes approximately 5 minutes to prepare, position, and to collect data with the catheter.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Sergio Waxman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahey Clinic, Burlington, MA, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infraredx', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director of Clinical & Regulatory Affairs', 'oldOrganization': 'InfraReDx Inc.'}}}}