Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 5:31 PM
Study NCT ID:
NCT06033495
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Ischemia After Coronary Sinus Reduction Stent Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial ischemia', 'timeFrame': '6 months', 'description': 'Change in myocardial flow reserve on 15O-H2O PET/CT'}], 'secondaryOutcomes': [{'measure': 'Change in angina burden', 'timeFrame': '6 months', 'description': 'Seattle angina questionnaire (SAQ-7) score ranging 0 (bad) -100 (good) will be assessed at baseline and after 6 months.'}, {'measure': 'Change in quality of life', 'timeFrame': '6 months', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) score ranging 0 (bad) -100 (good) will be assessed at baseline and after 6 months.'}, {'measure': 'Change in exercise capacity', 'timeFrame': '6 months', 'description': 'Maximum oxygen extraction on cardiopulmonary exercise test assessed at baseline and after 6 months.'}, {'measure': 'Change in coronary microcirculation', 'timeFrame': '6 months', 'description': 'Invasive assessment of coronary flow reserve (CFR) at baseline and at 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Angina Pectoris']}, 'descriptionModule': {'briefSummary': 'Chronic angina pectoris refractory to medical and revascularization therapies is a disabling medical condition and a major public health problem. Patients with refractory angina have limited treatment options. One proposed therapy modality is transcatheter implantation of a reduction stent in the coronary sinus. Coronary sinus reduction stents have been shown to reduce angina burden considerably and to improve quality of life. The reduction stent is assumed to increase myocardial perfusion and reduce myocardial ischemia, but the mechanism of action is poorly understood.\n\nThe aim of this project is to assess the myocardial ischemia burden in patients with refractory angina who are undergoing a transcatheter coronary sinus reducer procedure. This is a clinical non-randomized self-controlled cohort study with blinded outcome adjudication for changes in myocardial perfusion. Patients with refractory angina will be systematically examined before implantation of the coronary sinus reduction stent and after 6 months. The primary outcome, changes in myocardial perfusion on the gold standard 15O-H2O PET/CT will be evaluated on blinded perfusion scans where the stent is invisible. To provide context to the findings, we will also evaluate whether changes in myocardial ischemia are associated with less angina and better cardiac function parameters. Effects of stent implantation on angina symptoms and quality of life could be affected by a placebo effect.\n\nTreatment options for patients with refractory angina is needed, and results from the present study will explore if coronary sinus reduction stents are improving myocardial ischemia in this patient group. Signs of improved objective perfusion will inspire confidence in the method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease and refractory angina who are under clinical care are informed and screened for participation if consent is provided.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery disease and refractory angina\n* Clinical indication for coronary sinus reduction stent implantation\n* Written informed consent\n* Anticipated compliance with protocol\n\nExclusion Criteria:\n\n* Ineligibility for coronary sinus reduction stent implantation\n* Lack of informed consent\n* Not expected to comply with protocol'}, 'identificationModule': {'nctId': 'NCT06033495', 'acronym': 'MICS-Reduce', 'briefTitle': 'Myocardial Ischemia After Coronary Sinus Reduction Stent Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Myocardial Ischemia by 15O-H2O PET/CT in Patients With Coronary Artery Disease and Refractory Angina - Evaluation of the Coronary Sinus Reduction Stent Method', 'orgStudyIdInfo': {'id': '657796'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with refractory angina undergoing coronary sinus reduction stent implantation', 'interventionNames': ['Device: Coronary sinus reduction stent']}], 'interventions': [{'name': 'Coronary sinus reduction stent', 'type': 'DEVICE', 'description': 'Percutaneous stent implantation to reduce the dimension of the coronary sinus', 'armGroupLabels': ['Patients with refractory angina undergoing coronary sinus reduction stent implantation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Øyvind Lie, MD, PhD', 'role': 'CONTACT', 'email': 'oyvlie@gmail.com', 'phone': '+4793429011'}], 'overallOfficials': [{'name': 'Øyvind H Lie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We aim to share data upon request from other academic investigators, but await EC approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Øyvind Lie', 'investigatorAffiliation': 'Oslo University Hospital'}}}}