CHIP in Health and Disease

Sponsor
VASCage GmbH
Study ID
NCT07780552
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Disease
  • Clonal Cytopenia of Undetermined Significance (CCUS)
  • Clonal Hematopoiesis
  • Clonal Hematopoiesis of Indeterminate Potential
  • Myelodysplastic Syndrome
  • Myocardial Infarction (MI)
  • ST-elevation Myocardial Infarction (STEMI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Group A: Healthy Controls
    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.
  • Arm: 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 \<9.5).
  • Arm: Group C: Intermediate-/High-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).
  • Arm: 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.
  • Arm: 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.
  • Arm: Group F: Lower-Risk Myelodysplastic Syndrome (MDS)
    Participants aged ≥60 years with newly diagnosed (\<3 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.

Primary Outcome Measure

Inflammatory transcriptional profile of mutation-bearing immune cells [ Time Frame: Baseline ]

Central Contacts

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