ST-elevation Myocardial Infarction (STEMI)CHIP in STEMINCT07615023
Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction
An observational study of ST-elevation Myocardial Infarction (STEMI) and Clonal Hematopoiesis of Indeterminate Potential (CHIP), run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ST-elevation Myocardial Infarction (STEMI), Clonal Hematopoiesis of Indeterminate Potential (CHIP)
- What is being tested?
- Clonal hematopoiesis assessment and cardiac magnetic resonance imaging
- How many people
- 350 participants
- Where
- 1 siteAustria
- Study dates
- 20 Jun 2026to 20 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastian J Reinstadler, MD, PhD contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Ivan Lechner, MD, PhD, +43 512 504 83772, ivan.lechner@tirol-kliniken.at
Sebastian J Reinstadler, MD, PhD, +43 512 504 83772
About this study
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.
Read more
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).
Read the 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:
- Cardiac MRI (CMR) at 5±2 days post-PCI: MVO, IMH, infarct size (%LVMM), LV/RV ejection fraction, volumes, mass
- Targeted next-generation sequencing (NGS) for CHIP mutations (VAF ≥2%): DNMT3A, TET2, ASXL1, and other driver genes
- Single-cell RNA sequencing (scRNA-seq) of PBMCs at baseline and 12-month follow-up
- Serial blood biomarkers: hsCRP, IL-6, IL-18, NT-proBNP, troponin T, complete blood count
- 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.
- Conditions
- ST-elevation Myocardial Infarction (STEMI), Clonal Hematopoiesis of Indeterminate Potential (CHIP)
- Being tested
- Clonal hematopoiesis assessment and cardiac magnetic resonance imaging
- Keywords
- CHIP, STEMI, cardiac MRI, microvascular obstruction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonal hematopoiesis assessment and cardiac magnetic resonance imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Clonal hematopoiesis assessment and cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of microvascular injury
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.
Measured: 5 ± 2 days after primary percutaneous coronary intervention
Secondary outcomes (4)
Infarct size
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.
Measured: 5 ± 2 days after primary percutaneous coronary intervention
Left ventricular ejection fraction
Left ventricular ejection fraction assessed by cardiac magnetic resonance imaging in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.
Measured: 5 ± 2 days, 4 months, and 12 months after primary percutaneous coronary intervention
All-cause mortality
eath from any cause after study inclusion.
Measured: Within 12 months after study inclusion.
Hospitalization for heart failure
Hospitalization due to new or worsening heart failure after study inclusion.
Measured: Within 12 months after study inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start20 Jun 2026
- Primary completion20 Jun 2029 (estimated)
- Study completion20 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615023
- Sponsor's protocol ID
- 1195/2024
- Other IDs
- KLP1365525
- Acronym
- CHIP in STEMI
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Hematopoiesis of Indeterminate Potential and Infarct Severity in ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07615023
- Acronym / sponsor ID
- CHIP in STEMI / 1195/2024
- Conditions
- ST-elevation Myocardial Infarction (STEMI), Clonal Hematopoiesis of Indeterminate Potential (CHIP)
- Keywords
- CHIP, STEMI, cardiac MRI, microvascular obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 Jun 2029 (estimated)
- Study completion
- 20 Jun 2030 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- Cardiac MRI (CMR) at 5±2 days post-PCI: MVO, IMH, infarct size (%LVMM), LV/RV ejection fraction, volumes, mass
- Targeted next-generation sequencing (NGS) for CHIP mutations (VAF ≥2%): DNMT3A, TET2, ASXL1, and other driver genes
- Single-cell RNA sequencing (scRNA-seq) of PBMCs at baseline and 12-month follow-up
- Serial blood biomarkers: hsCRP, IL-6, IL-18, NT-proBNP, troponin T, complete blood count
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI Patients | – | Diagnostic Test: Clonal hematopoiesis assessment and cardiac magnetic resonance imagingPatients 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonal hematopoiesis assessment and cardiac magnetic resonance imagingParticipants 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. | Diagnostic test | STEMI Patients |
Primary outcome
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.
4 secondary outcomes
Infarct size
Time frame: 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
All-cause mortality
Time frame: Within 12 months after study inclusion.
Hospitalization for heart failure
Time frame: Within 12 months after study inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian J Reinstadler, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-elevation Myocardial Infarction (STEMI) and Clonal Hematopoiesis of Indeterminate Potential (CHIP), run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Lechner, MD, PhD (+43 512 504 83772, ivan.lechner@tirol-kliniken.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of microvascular injury (time frame: 5 ± 2 days after primary percutaneous coronary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.