About this trial
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.
This 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent has been obtained for participation in the study "Deconvolution of Clonal Hematopoiesis-Associated Inflammation in Health and Disease"; OR
Participant is enrolled in the Inn.Health study and has provided written informed consent; OR
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.
Age ≥60 years
Disqualifiers
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
History of rheumatologic, autoinflammatory, or autoimmune disease
Trial population
Adults aged ≥60 years will be recruited across six predefined cohorts representing the continuum from healthy aging to clonal hematopoiesis-associated hematologic and cardiovascular disease. The study population includes healthy controls, individuals with low-risk and intermediate/high-risk clonal hematopoiesis, patients with clonal cytopenia of undetermined significance (CCUS), patients with low-risk myelodysplastic syndrome (MDS), and patients with recent ST-segment elevation myocardial infarction (STEMI).
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
6
Trial groupsSee each trial group below.
Trial outcomes
Primary outcomes
Inflammatory transcriptional profile of mutation-bearing immune cells
Single-cell gene expression differences in predefined inflammatory pathways (including NLRP3 inflammasome, interferon signaling, and cGAS-STING-related pathways) between immune cells with and without clonal hematopoiesis-associated somatic variants and across study groups.
Sponsors and contacts
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VASCage GmbH
Lead sponsor
Medical University Innsbruck
Collaborator
This trial is not recruiting at the moment. You can still explore other options: