[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652810":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":27,"centralContacts":32,"locations":42,"responsibleParty":59,"collaborators":61,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":87,"overallStatus":109,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"VASCage GmbH","OTHER",[8,12,15,18,21,24],{"label":9,"type":10,"description":11,"interventionNames":10},"Group A: Healthy Controls",null,"Participants aged ≥60 years without detectable clonal hematopoiesis-associated somatic variants, no history of myocardial infarction or stroke, no cytopenia, no WHO-defined neoplasm, and no major surgery within the previous 3 months.",{"label":13,"type":10,"description":14,"interventionNames":10},"Group B: Low-Risk Clonal Hematopoiesis","Participants aged ≥60 years with clonal hematopoiesis carrying a somatic mutation in DNMT3A, TET2, ASXL1, or JAK2 (variant allele frequency ≥2%), no prior cardiovascular events, no cytopenia, no WHO-defined neoplasm, and a low Clonal Hematopoiesis Risk Score (CHRS \\\u003C9.5).",{"label":16,"type":10,"description":17,"interventionNames":10},"Group C: Intermediate-\u002FHigh-Risk Clonal Hematopoiesis","Participants aged ≥60 years with clonal hematopoiesis carrying a somatic mutation in DNMT3A, TET2, ASXL1, or JAK2 (variant allele frequency ≥2%), no prior cardiovascular events, no cytopenia, no WHO-defined neoplasm, and an intermediate or high Clonal Hematopoiesis Risk Score (CHRS \\>9.5).",{"label":19,"type":10,"description":20,"interventionNames":10},"Group D: Clonal Cytopenia of Undetermined Significance (CCUS)","Participants aged ≥60 years with clonal hematopoiesis-associated mutations and persistent unexplained cytopenia for at least 4 months who do not meet diagnostic criteria for a myeloid neoplasm based on bone marrow evaluation.",{"label":22,"type":10,"description":23,"interventionNames":10},"Group E: Cardiovascular Disease (Post-STEMI)","Participants aged ≥60 years with clonal hematopoiesis-associated mutations and a recent ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention within the previous 4 months, without prior stroke, coronary artery bypass graft surgery, cytopenia, or WHO-defined neoplasm.",{"label":25,"type":10,"description":26,"interventionNames":10},"Group F: Lower-Risk Myelodysplastic Syndrome (MDS)","Participants aged ≥60 years with newly diagnosed (\\\u003C3 months), untreated lower-risk myelodysplastic syndrome defined by an IPSS-R score \\>1.5 to 3 points and no history of myocardial infarction or stroke.",[28],{"name":29,"affiliation":30,"role":31},"Dominik Wolf","Medical University Innsbruck","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Kai Zimmer","CONTACT","+43 512 504 83895","kai.zimmer@i-med.ac.at",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Tina Pancheri","+4351255443513","tina.pancheri@vascage.at",[43],{"facility":30,"status":10,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Innsbruck","Tyrol","6020","Austria","AT",{"type":50,"coordinates":51},"Point",[52,53],11.39454,47.26266,{"lat":53,"lon":52},[56],{"name":29,"role":35,"phone":57,"phoneExt":10,"email":58},"+43 50504 24003","dominik.wolf@i-med.ac.at",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[62],{"name":30,"class":6},"100652810","chip-in-health-and-disease-100652810",false,"NCT07780552","CHIP in Health and Disease","DECONVOLUTION OF CLONAL HEMATOPOIESIS ASSOCIATED INFLAMMATION IN HEALTH AND DISEASE","CHIP2","Inclusion Criteria: Participants must be ≥18 years of age and meet at least one of the following criteria:\n\n* Written informed consent has been obtained for participation in the study \"Deconvolution of Clonal Hematopoiesis-Associated Inflammation in Health and Disease\"; OR\n* Participant is enrolled in the Inn.Health study and has provided written informed consent; OR\n* Participant is enrolled in the study \"Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction\" and has provided written informed consent.\n\nGroup A: Control Group (n=20)\n\n* Age ≥60 years\n* No detectable somatic variant identified by peripheral blood next-generation sequencing (NGS)\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* No cytopenia at study enrollment Group B: Low-Risk Clonal Hematopoiesis Risk Score (CHRS) Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with variant allele frequency (VAF) ≥2% in peripheral blood\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* No cytopenia at study enrollment\n* Low-risk CHRS (\\\u003C9.5 points) Group C: Intermediate-\u002FHigh-Risk CHRS Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* No cytopenia at study enrollment\n* Intermediate- or high-risk CHRS (\\>9.5 points) Group D: Clonal Cytopenia of Undetermined Significance (CCUS) Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood\n* No history of stroke or myocardial infarction\n* No surgery within the previous 3 months\n* No diagnosis of a WHO-defined neoplasm\n* Untreated, unexplained cytopenia present for ≥4 months\n* Hemoglobin \\\u003C13 g\u002FdL (men) or \\\u003C12 g\u002FdL (women), and\u002For absolute neutrophil count \\\u003C1.8 × 10⁹\u002FL, and\u002For platelet count \\\u003C150 × 10⁹\u002FL\n* No diagnostic criteria for a defined myeloid neoplasm based on bone marrow examination Group E: Cardiovascular Disease Group (n=20)\n* Age ≥60 years\n* Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood\n* ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) within the previous 4 months\n* No history of coronary artery bypass grafting (CABG)\n* No history of stroke\n* No cytopenia at study enrollment\n* No diagnosis of a WHO-defined neoplasm Group F: Low-Risk Myelodysplastic Syndrome (MDS) Group (n=20)\n* Age ≥60 years\n* Untreated, newly diagnosed (\\\u003C3 months from diagnosis) low-risk myelodysplastic syndrome according to the Revised International Prognostic Scoring System (IPSS-R score \\>1.5 to 3.0)\n* No history of stroke or myocardial infarction\n\nExclusion Criteria:\n\n* Treatment with immunosuppressive medication within the previous 4 weeks, including but not limited to systemic corticosteroids, methotrexate, other disease-modifying antirheumatic drugs (DMARDs), colchicine, TNF-α inhibitors, mTOR inhibitors, calcineurin inhibitors, or immunomodulatory antibodies\n* History of rheumatologic, autoinflammatory, or autoimmune disease",true,"ALL","18 Years",{"count":75,"type":76},120,"ESTIMATED","OBSERVATIONAL","Clonal hematopoiesis (CH), including clonal hematopoiesis of indeterminate potential (CHIP), is an age-associated condition characterized by the expansion of hematopoietic stem and progenitor cell clones carrying acquired somatic mutations. Although CH is associated with an increased risk of hematologic malignancies, its greater public health impact derives from its strong association with cardiovascular diseases, including coronary artery disease and stroke. Emerging evidence suggests that CH-associated mutations promote chronic inflammatory signaling in myeloid immune cells, thereby contributing to atherosclerosis and adverse cardiovascular remodeling.\n\nThis observational translational study aims to characterize the biological spectrum of clonal hematopoiesis across different stages of disease risk and manifestation. Using state-of-the-art single-cell and multi-omics approaches, the study will compare inflammatory pathways, immune cell states, and mutation-associated molecular programs among healthy individuals without CH, individuals with high-risk CH, and patients with CH-associated hematologic or cardiovascular disease. The ultimate goal is to identify shared and disease-specific mechanisms linking clonal hematopoiesis to adverse clinical outcomes and to generate insights for future preventive, anti-clonal, and anti-inflammatory therapeutic strategies.",[80,81,82,83,84,85,86],"Clonal Hematopoiesis","Clonal Hematopoiesis of Indeterminate Potential","Clonal Cytopenia of Undetermined Significance (CCUS)","Myelodysplastic Syndrome","Cardiovascular Disease","Myocardial Infarction (MI)","ST-elevation Myocardial Infarction (STEMI)",[80,88,89,90,91,92,93,94,84,95,96,97,82,98,99,100,101,102,103,104,105,106,107,108],"Clonal Hematopoiesis of Indeterminate Potential (CHIP)","Somatic Mutations","DNMT3A","TET2","ASXL1","Inflammation","Myeloid Cells","Atherosclerosis","Myocardial Infarction","STEMI","Myelodysplastic Syndromes (MDS)","Single-Cell RNA Sequencing","Multi-Omics","Immune Profiling","NLRP3 Inflammasome","cGAS-STING Pathway","Precision Medicine","Cardiovascular Risk","Healthy Aging","Chronic Inflammation","Biomarkers","NOT_YET_RECRUITING","2026-08-18",{"date":112,"type":113},"2026-08-21","ACTUAL",{"date":115,"type":76},"2026-10",{"date":117,"type":76},"2027-03",{"name":5,"class":6},1]