Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT02510092
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-07-24', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intravascular ultrasound findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Minimum Lumen Area (MLA)'}, {'measure': 'Intravascular ultrasound findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Percent Atheroma Volume (PAV)'}, {'measure': 'Intravascular ultrasound findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Area Stenosis (AS)'}, {'measure': 'Intravascular ultrasound findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Negative or positive remodelling index (RI)'}, {'measure': 'Intravascular ultrasound findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Intimal thickness (IT)'}, {'measure': 'Intravascular ultrasound findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Calcification Index (CI)'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Intima to Media ratio (I/M ratio)'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Excentric intima hyperplasia'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Thin Cap Fibroatheroma presence (TCFA)'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Macrophage infiltration'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Intramural hematoma formation'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Intimal laceration'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Microchannel formation'}, {'measure': 'Optical coherence tomography findings in coronaries', 'timeFrame': 'At index procedure', 'description': 'Lipid pool formation'}], 'primaryOutcomes': [{'measure': 'Major adverse cardiac and cerebral events', 'timeFrame': 'From index procedure to 5 years', 'description': 'Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autoimmune Diseases', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.', 'detailedDescription': 'The aim of this study is to assess in vivo intracoronary anatomy using intravascular ultrasound and optical coherence tomography and assess the efficacy and safety of new generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart disease patient population.\n\nThe following four well defined systemic autoimmune entities are linked to increased cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis and systemic lupus erythematosus. One of the main causes of death in systemic autoimmune subjects is cardiovascular disease. In-vivo intracoronary anatomy and pathology regarding systemic autoimmune diseases is unknown. Furthermore, all forms of revascularization in such patients yield sub-optimal results, with poor outcomes using even the most modern drug eluting metallic stents. This may be linked to a long term exaggerated chronic inflammation response to the metallic components. Thus, fully bioresorbable vascular scaffolds may prove more efficacious in systemic autoimmune subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18+ years\n* Signed and dated informed consent form\n* Manifest autoimmune disease, consisting either of: rheumatoid arthritis or systemic lupus erythematosus or systemic sclerosis or mixed connective tissue disease under the care of a clinical immunologist\n* Clinical indication for a coronary angiography as determined by a cardiologist\n\nExclusion Criteria:\n\n* Age of 75+ years\n* Glomerular filtration rate of under 30 ml/min\n* Severely decreased left ventricular function (ejection fraction \\<35%)\n* Pregnancy or nursing\n* Unclear immunological diagnosis'}, 'identificationModule': {'nctId': 'NCT02510092', 'briefTitle': 'Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University Heart and Vascular Center'}, 'officialTitle': 'In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients', 'orgStudyIdInfo': {'id': 'Im-CAD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coronary artery diseae with revascularization indicated', 'description': 'Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization.', 'interventionNames': ['Device: Percutaneous coronary intervention with new generation fully resorbable scaffold']}, {'type': 'NO_INTERVENTION', 'label': 'Coronary artery disease not requiring revascularization', 'description': 'Subjects with coronary artery disease that do not require revascularization.'}], 'interventions': [{'name': 'Percutaneous coronary intervention with new generation fully resorbable scaffold', 'type': 'DEVICE', 'armGroupLabels': ['Coronary artery diseae with revascularization indicated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University Heart and Vascular Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University Heart and Vascular Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Debrecen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}