Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction (CHIP in STEMI)

May 22, 2026 updated by: Medical University Innsbruck

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background and Rationale:

CHIP mutations - particularly in TET2 and DNMT3A - promote a pro-inflammatory state in hematopoietic cells. Preclinical data demonstrate that TET2-deficient macrophages exhibit exaggerated NLRP3 inflammasome activation and IL-1β secretion, while DNMT3A mutations impair immune resolution after myocardial ischemia. This enhanced inflammatory signaling may worsen myocardial ischemia-reperfusion injury (IRI), thereby increasing MVO, IMH, and infarct size in CHIP carriers presenting with STEMI.

Study Design:

Prospective, observational, single-center cohort study. No intervention beyond standard of care.

Study Population:

350 patients aged 18-75 years with STEMI undergoing primary PCI at the University Clinic of Internal Medicine III - Cardiology and Angiology, Medical University of Innsbruck. A minimum of 90 female participants will be enrolled.

Key Inclusion Criteria:

  • Age 18-75 years
  • STEMI with symptom onset ≤12 hours before PCI
  • Successful primary PCI of culprit lesion
  • Written informed consent

Key Exclusion Criteria:

  • Prior myocardial infarction or known cardiomyopathy
  • Known hematological malignancy
  • Contraindication to CMR (pacemaker, severe claustrophobia, eGFR <30 mL/min/1.73m²)
  • Cardiogenic shock requiring mechanical circulatory support
  • Life expectancy <12 months due to non-cardiac cause
  • Pregnancy

Assessments:

  1. Cardiac MRI (CMR) at 5±2 days post-PCI: MVO, IMH, infarct size (%LVMM), LV/RV ejection fraction, volumes, mass
  2. Targeted next-generation sequencing (NGS) for CHIP mutations (VAF ≥2%): DNMT3A, TET2, ASXL1, and other driver genes
  3. Single-cell RNA sequencing (scRNA-seq) of PBMCs at baseline and 12-month follow-up
  4. Serial blood biomarkers: hsCRP, IL-6, IL-18, NT-proBNP, troponin T, complete blood count
  5. Clinical follow-up visits at 12, 24, and 48 months

Primary Endpoint:

Presence of microvascular obstruction (MVO) and/or intramyocardial hemorrhage (IMH) on CMR at 5±2 days post-PCI in CHIP carriers versus non-carriers.

Secondary Endpoints:

  • Infarct size (% left ventricular myocardial mass, %LVMM)
  • LV and RV ejection fraction, end-diastolic/systolic volumes, myocardial mass
  • MACE: all-cause mortality, non-fatal reinfarction, hospitalization for heart failure at 12, 24, and 48 months
  • Changes in CHIP mutation variant allele frequency (VAF) over time
  • Differential gene expression in immune cell subsets by scRNA-seq
  • Biomarker trajectories (NT-proBNP, hsCRP, IL-6)

Ethics and Regulatory:

The study protocol has been approved by the Research Ethics Committee of the Medical University of Innsbruck and is conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines. All participants provide written informed consent prior to study inclusion. The study is funded by the KLiF (Klinisch-Interne Forschung) program of the Medical University of Innsbruck.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sebastian J Reinstadler, MD, PhD
  • Phone Number: +43 512 504 83772

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University of Innsbruck
        • Contact:
        • Contact:
          • Sebastian J Reinstadler, MD, PhD
          • Phone Number: +43 512 504 83772

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult female and male patients aged 18 to 75 years with a first acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention within 12 hours after symptom onset. Patients will be screened at the coronary care unit of the Medical University of Innsbruck. Eligible patients will be invited to participate after primary percutaneous coronary intervention and after assessment of inclusion and exclusion criteria. Standard clinical care and secondary prevention will be performed according to current guideline recommendations.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention
  • 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
  • Prior oncologic treatment with chemotherapy, radiotherapy, or radioisotopes
  • 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 viral infection associated with systemic inflammation
  • Active autoimmune disease or chronic systemic inflammatory disorder
  • Chronic kidney disease with creatinine clearance less than 30 mL/min/1.73 m2
  • Contraindication to cardiac magnetic resonance imaging
  • Pre-ST-elevation myocardial infarction life expectancy of less than 1 year
  • Participation in an interventional trial
  • Limited possibility to attend follow-up examinations, for example residence abroad
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of microvascular injury
Time Frame: 5 ± 2 days after primary percutaneous coronary intervention
Presence of microvascular injury, defined as microvascular obstruction and/or intramyocardial hemorrhage, assessed by cardiac magnetic resonance imaging in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. The outcome will be analyzed according to the presence or absence of clonal hematopoiesis of indeterminate potential.
5 ± 2 days after primary percutaneous coronary intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infarct size
Time Frame: 5 ± 2 days after primary percutaneous coronary intervention
Infarct size expressed as percentage of left ventricular myocardial mass, assessed by cardiac magnetic resonance imaging in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. The outcome will be analyzed according to the presence or absence of clonal hematopoiesis of indeterminate potential.
5 ± 2 days after primary percutaneous coronary intervention
Left ventricular ejection fraction
Time Frame: 5 ± 2 days, 4 months, and 12 months after primary percutaneous coronary intervention
Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.
5 ± 2 days, 4 months, and 12 months after primary percutaneous coronary intervention
All-cause mortality
Time Frame: Within 12 months after study inclusion.
eath from any cause after study inclusion.
Within 12 months after study inclusion.
Hospitalization for heart failure
Time Frame: Within 12 months after study inclusion.
Hospitalization due to new or worsening heart failure after study inclusion.
Within 12 months after study inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1195/2024
  • KLP1365525 (Other Grant/Funding Number: Austrian Science Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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