NCT07615023Recruiting
Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
Clonal Hematopoiesis of Indeterminate Potential (CHIP) refers to the age-related expansion of hematopoietic stem cell clones carrying somatic mutations in leukemia-associated driver genes (e.g., DNMT3A, TET2, ASXL1) in the absence of a hematological malignancy. CHIP has been identified as an independent cardiovascular risk factor associated with increased rates of myocardial infarction, stroke, and cardiovascular mortality, likely mediated through enhanced inflammatory signaling in mutant macrophages and monocytes. ST-elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate reperfusion by primary percutaneous coronary intervention (PCI). Despite successful reperfusion, adverse cardiac remodeling and heart failure may occur depending on myocardial injury severity, microvascular obstruction (MVO), and intramyocardial hemorrhage (IMH) - phenomena substantially driven by ischemia-reperfusion injury and the inflammatory response. The CHIP in STEMI study is a prospective, observational, single-center cohort study at the Medical University of Innsbruck investigating whether CHIP - detected by targeted next-generation sequencing - is associated with greater infarct severity and worse cardiac outcomes in STEMI patients undergoing primary PCI. The primary endpoint is the presence of MVO and/or IMH on cardiac MRI (CMR) at 5±2 days post-PCI. Secondary endpoints include infarct size, left and right ventricular function, major adverse cardiovascular events (MACE), and immune cell transcriptome profiling by single-cell RNA sequencing. 350 patients (18-75 years, minimum 90 female) will be enrolled over 36 months and followed for 4 years (2026-2030).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 22 May 2026
- Start date
- 20 Jun 2026
- Primary completion date
- 20 Jun 2029
- Lead sponsor
- Medical University Innsbruck
- Diseases
- Coronary artery disease
- NCT number
- NCT07615023
What you commit to
- Study type: Observational
- Planned participants: 350
- From 20 Jun 2026 to the primary completion date, 20 Jun 2029
- 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
- Prior myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention
- Prior oncologic treatment with chemotherapy, radiotherapy, or radioisotopes
Other illness
- Persistent hemodynamic instability, Killip class greater than 2 including cardiogenic shock, or resuscitated cardiac arrest not allowing cardiac magnetic resonance imaging
- Known active or prior malignancy, including hematologic malignancies or myelodysplastic syndromes
- Chronic viral infection associated with systemic inflammation
- Active autoimmune disease or chronic systemic inflammatory disorder
- Contraindication to cardiac magnetic resonance imaging
- Pre-ST-elevation myocardial infarction life expectancy of less than 1 year
Lab values
- Abnormal baseline complete blood count with clinically significant cytopenia, defined as leukocytes less than 3.0 x 10\^9/L, platelets less than 100 x 10\^9/L, or hemoglobin less than 10 g/dL
- Chronic kidney disease with creatinine clearance less than 30 mL/min/1.73 m2
Other
- Participation in an interventional trial
- Limited possibility to attend follow-up examinations, for example residence abroad
- Pregnancy
Who the study is looking for
- Diagnosis of first acute ST-elevation myocardial infarction according to current European Society of Cardiology guidelines
- Symptoms consistent with ST-elevation myocardial infarction lasting more than 30 minutes and less than 12 hours before primary percutaneous coronary intervention
- Treatment with primary percutaneous coronary intervention
- Age 18 to 75 years
- Written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
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 of Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.