Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT02237456
Status:
COMPLETED
Last Update Posted:
2015-03-13
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DOCTOR Compare - A Study in the "DOCTOR" Series (Does Optical Coherence Tomography Optimize Revascularization?"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of fibrous tissue (maximum scan penetrance)', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of lipid plaque (signal intensities under the fibrous cap)', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of vessel dissection (exploratory)', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of the fibrous cap (minimum thickness)', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Detection of stent struts', 'timeFrame': 'Baseline', 'description': 'Stent evaluation obtained by Lunawawe recordings versus OPTIS recordings (including areas with thrombus, plaque, bare metal stent, bioresorbable stents, 3D reconstruction of stents (qualitative and quantitative assessment of stent visualization degree)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Atherosclerosis', 'PCI', 'OCT', 'Optical coherence tomography', 'Stent', 'Bioresorbable stents'], 'conditions': ['Coronary Disease', 'Myocardial Infarction', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare optical coherence tomography (OCT) scans performed in the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after implantation of stents or bioresorbable scaffolds.', 'detailedDescription': "Standard treatment of persons with narrowings of the heart's coronary artery is balloon treatment with implantation of stents (Percutaneous coronary intervention (PCI )). To evaluate disease in coronary arteries prior to, and during PCI , X-ray fluoroscopy with contrast is used. X-ray fluoroscopy produces little information of any disease changes in the vessel wall and implanted stents and especially polylactid acid (PLA) type bioresorbable scaffolds are visualized poorly .\n\nOptical coherence tomography (OCT) is a light-based, high resolution, imaging modality for intra coronary assessment of tissue and implants. Currently two CE-marked OCT systems are used in clinical practice in (Illumien OPTIS, St. Jude Medical , Minnesota, USA and Lunawave, Terumo , Tokyo, Japan). It is a common assumption that the scanning images for the two systems are similar and are interpreted the same way.\n\nThe aim of the study is to assess if tissue, stents and PLA type scaffolds are presented with same characteristics by the two systems.\n\nSame segment scans by the two systems will be systematically compared and reported.\n\nDifferences in scans by the two systems may have implications for the interpretation and thus may affect clinical decisions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing percutaneous coronary intervention (PCI) at Department of Cardiology, Aarhus University Hospital Skejby, will be invited to participate in the study. 12 patients will be included; 4 with acute ST-elevation myocardial infarct (STEMI) and 8 stable or stabilized patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for intervention with PCI on the right or left coronary artery\n* Age \\>18 years\n* Must be able to give written informed consent\n\nExclusion Criteria:\n\n* Expected life span of less than one year\n* Pregnancy or possible pregnancy\n* Cardiogenic shock\n* Especially tortuous vessels\n* Renal impairment (creatinine\\> 100 micromoles / L)'}, 'identificationModule': {'nctId': 'NCT02237456', 'briefTitle': 'DOCTOR Compare - A Study in the "DOCTOR" Series (Does Optical Coherence Tomography Optimize Revascularization?"', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare', 'orgStudyIdInfo': {'id': '1-10-72-59-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Comparison of OCT scans', 'type': 'PROCEDURE'}, {'name': 'Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N, Denmark', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Niels R Holm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital Skejby', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Niels Ramsing Holm', 'investigatorAffiliation': 'Aarhus University Hospital Skejby'}}}}