NCT07780552Not yet recruiting

CHIP in Health and Disease

Deconvolution of Colonal Hematopoiesis Associated Inflammation in Health and Disease

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Observational
Enrollment: 120 (estimated)
First submitted: 18 Aug 2026
Start date: 1 Oct 2026
Primary completion date: 31 Mar 2027
Lead sponsor: VASCage GmbH
Diseases: Coronary artery disease, Myelodysplastic syndromes
NCT number: NCT07780552

What you commit to

Study type: Observational
Planned participants: 120
From 1 Oct 2026 to the primary completion date, 31 Mar 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

History of rheumatologic, autoinflammatory, or autoimmune disease

Who the study is looking for

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.
- Group A: Control Group (n=20)
Age ≥60 years
No detectable somatic variant identified by peripheral blood next-generation sequencing (NGS)
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
No cytopenia at study enrollment Group B: Low-Risk Clonal Hematopoiesis Risk Score (CHRS) Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with variant allele frequency (VAF) ≥2% in peripheral blood
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
No cytopenia at study enrollment
Low-risk CHRS (\<9.5 points) Group C: Intermediate-/High-Risk CHRS Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
No cytopenia at study enrollment
Intermediate- or high-risk CHRS (\>9.5 points) Group D: Clonal Cytopenia of Undetermined Significance (CCUS) Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood
No history of stroke or myocardial infarction
No surgery within the previous 3 months
No diagnosis of a WHO-defined neoplasm
Untreated, unexplained cytopenia present for ≥4 months
Hemoglobin \<13 g/dL (men) or \<12 g/dL (women), and/or absolute neutrophil count \<1.8 × 10⁹/L, and/or platelet count \<150 × 10⁹/L
No diagnostic criteria for a defined myeloid neoplasm based on bone marrow examination Group E: Cardiovascular Disease Group (n=20)
Age ≥60 years
Somatic variant in DNMT3A, TET2, ASXL1, or JAK2 with VAF ≥2% in peripheral blood
ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) within the previous 4 months
No history of coronary artery bypass grafting (CABG)
No history of stroke
No cytopenia at study enrollment
No diagnosis of a WHO-defined neoplasm Group F: Low-Risk Myelodysplastic Syndrome (MDS) Group (n=20)
Age ≥60 years
Untreated, newly diagnosed (\<3 months from diagnosis) low-risk myelodysplastic syndrome according to the Revised International Prognostic Scoring System (IPSS-R score \>1.5 to 3.0)
No history of stroke or myocardial infarction

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Medical University Innsbruck Coordinator of this site? Confirm its status	Innsbruck	Austria	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.