Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 6:52 AM
Study NCT ID:
NCT05519735
Status:
RECRUITING
Last Update Posted:
2023-05-25
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphatic Organs and Myocardium After Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D009205', 'term': 'Myocarditis'}], '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': 'D009202', 'term': 'Cardiomyopathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CXCR4 PET-derived uptake after myocardial infarction', 'timeFrame': '12 months', 'description': 'Semi-quantitative assessment of CXCR4-derived radiotracer accumulation in the myocardium, mediastinal lymph nodes, bone marrow and spleen in patients after myocardial infarction. For quantitative analysis, standardized uptake values (SUV) will be calculated in organs of interest.'}], 'secondaryOutcomes': [{'measure': 'Correlation of quantitative parameters (SUV) with peripheral lymphocytes', 'timeFrame': '12 months', 'description': 'SUV of organs of interest are correlated to the phenotype of peripheral lymphocytes in the peripheral blood after myocardial infarction.'}, {'measure': 'Time course of SUV after myocardial infarction', 'timeFrame': '12 months', 'description': 'PET/CT scans for each patient will be allocated to either day 3-4 or day 5-8 after myocardial infarction. SUV of organs of interest will be correlated to time point of imaging.'}, {'measure': 'Correlation of myocardial damage to SUV', 'timeFrame': '12 months', 'description': 'CMR will determine the extend of myocardial damage as necrotic volume, volume of MVO and myocardial edema. These findings will be correlated to SUV.'}, {'measure': 'Correlation of SUV with the clincial course', 'timeFrame': '12 months', 'description': 'Myocardial function (LVEF) and scar volumes as determined by CMR will be correlated to the intital SUV in order to correlate the clinical outcome to the tracer activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CXCR4', 'CMR', 'Lymphatic organs', 'Myocardial Infarction'], 'conditions': ['Myocardial Infarction', 'Myocardial Injury', 'Myocardial Inflammation']}, 'descriptionModule': {'briefSummary': 'The adaptive immune response plays an important role in myocardial healing and remodeling after acute myocardial infarction in patients. Therefore, the involved lymphocytes represent a novel target for therapeutic interventions. However, there are no established blood-derived biomarkers to predict the quantity and quality of the adaptive immune response to cardiac injury. Multimodal imaging of the heart and immunologic organs might provide such information.\n\nRecent retrospective analysis of patients after MI revealed enlarged mediastinal lymph nodes associated with increased CXCR4 radiotracer accumulation, thereby indicating that CXCR4 PET-based lymph node imaging provides a non-invasive quantitative readout of the local adaptive immune response. These considerations are further fuelled by the fact that, within lymph nodes, CXCR4 is expressed almost exclusively on lymphocytes, whereas various other cell types express CXCR4 within the myocardium.\n\nThis leads to the hypothesis that the size of mediastinal lymph nodes and their respective CXCR4 PET signals correlate with the adaptive immune response to cardiac injury and might provide predictive information for functional cardiac decline during follow-up.\n\nThis prospective clinical study will use multimodal imaging to monitor chemokine receptor 4 (CXCR4) expression in the lymph nodes, myocardium, spleen, and bone marrow after acute MI. The combination of cardiac magnetic resonance (CMR), echocardiography, and positron emission tomography (PET) along with blood collection for immunophenotyping will allow to determine i) if the size of mediastinal lymph nodes and their respective PET-derived CXCR4 signals at baseline correlate with the adaptive immune response to acute cardiac injury; and ii) if they predict cardiac adverse remodelling during longitudinal follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization\n* stable clinical course\n* male/female, above 18 years old\n\nExclusion Criteria:\n\n* hemodynamic instablity \\> 48 h after immediate catherization\n* known CAD\n* known structural heart disease\n* multi vessel disease\n* NSTEMI\n* sarcoidosis\n* immunosuppressive therapy\n* acute inflammatory disease\n* no consent obtainable\n* contraindiations for CMR\n* impaired renal function\n* active cardiac implants, ferromagnetic implants\n* pregnancy, breast-feeding'}, 'identificationModule': {'nctId': 'NCT05519735', 'acronym': 'LOMI', 'briefTitle': 'Lymphatic Organs and Myocardium After Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Multimodal Characterization of Lymphatic Organs and Myocardium in Patients After Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '192/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Multimodal imaging', 'description': 'Multimodal imaging approach. This includes a CXCR4 targeted PET/CT (\\[68Ga\\]Pentixafor) during the acute hospital stay, and serial CMR and Echo imaging.', 'interventionNames': ['Diagnostic Test: Multimodality Imaging']}], 'interventions': [{'name': 'Multimodality Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients receive CXCR4-targeted PET/CT, CMR and Echo', 'armGroupLabels': ['Multimodal imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97070', 'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Willibald Hochholzer, Professor', 'role': 'CONTACT'}, {'role': 'CONTACT', 'phone': '+49 931 7910'}], 'facility': 'Klinikum Würzburg Mitte, Medizinische Klinik', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '97080', 'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Theresa Reiter', 'role': 'CONTACT', 'email': 'reiter_t@ukw.de', 'phone': '+4993120139944'}, {'name': 'Rudolf Werner', 'role': 'CONTACT', 'email': 'werner_r1@ukw.de', 'phone': '+4993120135906'}], 'facility': 'University Hospital Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'centralContacts': [{'name': 'Theresa Reiter, MD', 'role': 'CONTACT', 'email': 'reiter_t@ukw.de', 'phone': '+4993120139944'}, {'name': 'Rudolf Werner, MD', 'role': 'CONTACT', 'email': 'werner_r1@ukw.de', 'phone': '+4993120135906'}], 'overallOfficials': [{'name': 'Theresa Reiter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuerzburg University Hospital'}, {'name': 'Rudolf Werner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuerzburg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Theresa Reiter', 'investigatorAffiliation': 'Wuerzburg University Hospital'}}}}