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

NCT07615023 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2026-05-29

No results posted yet for this study

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).

Conditions

  • ST-elevation Myocardial Infarction (STEMI)
  • Clonal Hematopoiesis of Indeterminate Potential (CHIP)

Interventions

DIAGNOSTIC_TEST

Clonal hematopoiesis assessment and cardiac magnetic resonance imaging

Participants will undergo blood sampling for assessment of clonal hematopoiesis of indeterminate potential by targeted next-generation sequencing and cardiac magnetic resonance imaging for assessment of myocardial injury, including microvascular obstruction, intramyocardial hemorrhage, infarct size, ventricular function, and myocardial tissue characteristics. Additional biomarker and inflammatory profiling will be performed according to the study protocol.

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-20
Primary Completion
2029-06-20
Completion
2030-06-20

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07615023 on ClinicalTrials.gov