Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-30 @ 1:27 AM
Study NCT ID:
NCT02254668
Status:
UNKNOWN
Last Update Posted:
2014-10-02
First Post:
2013-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002985', 'term': 'Clinical Protocols'}, {'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-29', 'studyFirstSubmitDate': '2013-12-29', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intimal Thickness', 'timeFrame': 'Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV', 'description': 'Assessment is usually performed by intracoronary angiography and endomyocardial biopsy which is routinely performed \\<1 year after heart transplantation. Furthermore, assessment interval will be defined according to the result of these investigational procedures. If there is a diagnosis of CAV the interval will be one year, if not a follow-up examination in two years will be sufficient.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intima', 'thickness', 'transplantation', 'cardiology', 'immunosuppression'], 'conditions': ['Intimal Proliferation', 'Immunosuppression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.octnews.org', 'label': 'Informations about Optical Coherence Tomography (OCT)'}]}, 'descriptionModule': {'briefSummary': 'Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.', 'detailedDescription': 'In summary, the aim of the study is to examine the effect of the immunosuppressive agent Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV).\n\nTherefore the study is divided in three sections:\n\nSubstudy 1: Evaluation of morphological differences between between CAD and CAV.\n\nSubstudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific immunosuppressive protocol in patients with CAV.\n\nSubstudy 3: Prospective, randomized analysis of the influence of different immunosuppressive protocols in patients with CAV.\n\nPrimary endpoint of the study will be the adaption of intimal thickness after 10 years, analysed by means of optical coherence tomography.\n\nIn addition to the explanations above the most important in- and exclusion criteria are listed below:\n\nInclusion Criteria:\n\n* Patients after heart transplantation\n* Patients with coronary artery disease (CAD)\n* Age 18-80 years\n\nExclusion Criteria:\n\n* Contraindication of Everolimus/Sirolimus or adjuvants\n* Renal insufficiency (Creatinine \\> 265 µmol/l)\n* Cardiogenic shock or patients with Killip\\*-Class III or IV (\\*name)\n* Pregnant or breast feeding females\n* insufficient contraception (only for substudy 3)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with heart transplantation\n* Patient with coronary artery disease\n* Age between 18 and 80 years\n\nExclusion Criteria:\n\n* Renal insufficiency (\\> 265 µmol/l)\n* Incapability to give informed consent\n* Cardiogenic shock of patient with KILLIP III or IV\n* pregnant or breast feeding females\n* insufficient contraception (only for substudy 3)'}, 'identificationModule': {'nctId': 'NCT02254668', 'acronym': 'OCTandCAV', 'briefTitle': 'Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Intracoronary Analysis of Cardiac Allograft Vasculopathy in Comparison to Coronary Artery Disease by Means of Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'KEK-ZH_Nr. 2012-0409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus (Certican®)', 'description': 'Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). No protocol with Mycophenolate mofetil (CellCept®). Daily dosage administered depending on blood concentration (control interval 6-12 months)', 'interventionNames': ['Other: Protocol with Everolimus (Certican®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mycophenolate mofetil (CellCept®)', 'description': 'Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). No protocol with Everolimus (Certican®). Daily dosage administered depending on blood concentration (control interval 6-12 months)', 'interventionNames': ['Other: Protocol with Mycophenolate mofetil (CellCept®)']}], 'interventions': [{'name': 'Protocol with Everolimus (Certican®)', 'type': 'OTHER', 'otherNames': ['Randomizaiton by SecuTrial'], 'description': 'Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).', 'armGroupLabels': ['Everolimus (Certican®)']}, {'name': 'Protocol with Mycophenolate mofetil (CellCept®)', 'type': 'OTHER', 'otherNames': ['Randomizaiton by SecuTrial'], 'description': 'Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).', 'armGroupLabels': ['Mycophenolate mofetil (CellCept®)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christian Templin, MD, PhD', 'role': 'CONTACT', 'email': 'christian.templin@usz.ch', 'phone': '+41 (0)44 / 255 9585'}, {'name': 'Frank Ruschitzka, Professor', 'role': 'CONTACT', 'email': 'frank.ruschitzka@usz.ch', 'phone': '+41 (0)44 / 255 3957'}, {'name': 'Christian Templin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Zurich, Division of Cardiology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Christian Templin, MD, PhD', 'role': 'CONTACT', 'email': 'christian.templin@usz.ch', 'phone': '+41 (0)44 / 255 9585'}, {'name': 'Frank Ruschitzka, Professor', 'role': 'CONTACT', 'email': 'frank.ruschitzka@usz.ch', 'phone': '+41 (0)44 / 255 3957'}], 'overallOfficials': [{'name': 'Christian Templin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich (Switzerland), Division of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}