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Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Austria
Medical University of Innsbruck
RECRUITING
Innsbruck
Contact Information
Primary
Ivan Lechner, MD, PhD
ivan.lechner@tirol-kliniken.at
+43 512 504 83772
Backup
Sebastian J Reinstadler, MD, PhD
+43 512 504 83772
Time Frame
Start Date: 2026-06-20
Estimated Completion Date: 2030-06-20
Participants
Target number of participants: 350
Treatments
STEMI Patients
Patients presenting with ST-elevation myocardial infarction (STEMI) who undergo successful primary percutaneous coronary intervention (PCI). All consecutive eligible patients are enrolled regardless of CHIP mutation status. This single cohort is analyzed based on CHIP presence/absence and specific CHIP mutation type (e.g., DNMT3A, TET2, ASXL1).
Sponsors
Leads: Medical University Innsbruck

This content was sourced from clinicaltrials.gov