ST Elevation Myocardial InfarctionNCT04939805
CRP Apheresis in STEMI
A study testing Selective CRP apheresis using the PentraSorb®-CRP system in people with ST Elevation Myocardial Infarction and C-Reactive Protein, run by Medical University Innsbruck at 5 sites in 2 countries.
Trial summary
Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ST Elevation Myocardial Infarction, C-Reactive Protein, Apheresis
- What is being tested?
- Selective CRP apheresis using the PentraSorb®-CRP system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Apr 2021to 15 Dec 2026
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
- Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
- CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
- Eligible for primary PCI
- Age ≥18 years
- Written informed consent
Who cannot join
- Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
- Persistent hemodynamic instability (Killip class >2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
- The patient is febrile (temperature >38°C) or has experienced an acute infection with fever in the last 14 days.
- CRP >15 mg/l at time of hospital admission.
- Chronic inflammatory disease.
- Known history of severe hepatic failure
Show all 12Show fewer
- Chronic kidney disease with a creatinine clearance <30ml/min./1.73m²
- Contraindication to CMR.
- Pre-STEMI life expectancy of <1 year
- Participation in another interventional trial
- Limited possibility to join the follow-up examinations (e.g. patient lives abroad)
- Pregnancy
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Austria3 sites, 3 recruiting
- Recruiting
University Clinic for Cardiology and Nephrology, Medical University of Graz
Graz, 8036
Heiko Bugger, MD
Heiko Bugger, MD
- Recruiting
University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology.
Innsbruck, 6020
Sebastian J Reinstadler, MD, PhD, sebastian.reinstadler@gmail.com
Gert Klug, MD
- Not yet recruiting
University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg
Salzburg, 5020
Lukas J Motloch, MD, PhD
Lukas J Motloch, MD, PhD
Germany2 sites, 2 recruiting
- Recruiting
Leipzig Heart Center
Leipzig, 04289
Hans-Josef Feistritzer, MD, PhD
Holger Thiele, MD
- Not yet recruiting
Medical Clinic II - University Heart Center Lübeck
Lübeck, Schleswig-Holstein, 23538
Thomas Stiermaier, MD
Ingo Eitel, Prof.
About this study
Official title: Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction
Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.
Objective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.
Read more
Design: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.
Innovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.
- Being tested
- Selective CRP apheresis using the PentraSorb®-CRP system
- Keywords
- Cardiac magnetic resonance imaging
- 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.
Selective CRP apheresis using the PentraSorb®-CRP systemDevice
Selective CRP apheresis as an adjunct to standard of care. Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
| Study group | Role | What they receive |
|---|---|---|
| Selective CRP apheresis as an adjunct to standard of care | Experimental | Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI. Receives: Device: Selective CRP apheresis using the PentraSorb®-CRP system |
| Standard of care according to current guideline recommendations | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
Infarct size expressed as % of left ventricular myocardial mass (LVMM) as visualized by cardiac magnetic resonance (CMR) imaging at 5 ± 2 days post PCI
Measured: 5 ± 2 days post PCI
Secondary outcomes (16)
Safety endpoint
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) during hospitalization for the index event
Measured: during hospitalization for the index event
All-cause mortality or hospitalization for heart failure within 12 months after randomization
All-cause mortality or hospitalization for heart failure within 12 months after randomization (endpoint of interest with respect to the two-stage adaptive design)
Measured: within 12 months after randomization
CMR endpoints defined as: Left ventricular ejection fraction and microvascular obstruction and exploratory (intramyocardial hemorrhage, edema extent, myocardial salvage, native T1 mapping, strain)
CMR endpoints will be assessed at baseline, 4 and 12 months CMR follow-up study and are defined according to the Journal of American College of Cardiology Scientific Expert Consensus document.
Measured: at baseline, 4 months and 12 months after PCI for STEMI
Hospitalization for heart failure within 12 months after randomization
Measured: within 12 months after randomization
Cardiovascular mortality at 12 months
Measured: within 12 months after randomization
CRP concentrations
CRP concentrations during index hospitalization
Measured: during hospitalization for the index event
Left ventricular thrombus formation
Measured: 5 ± 2 days, 4 months, 12 months post PCI
Biomarker concentrations of myocardial necrosis (enzymatic infarct size; high-sensitivity troponin T)
Measured: at baseline, 4 months, 12 months post PCI
Biomarker concentrations of hemodynamic stress (N-terminal pro-B-Type Natriuretic Peptide)
Measured: at baseline, 4 months, 12 months post PCI
Renal function (eGFR)
as measured by the MDRD and CKD-EPI formula
Measured: during hospitalization for the index event
Renal function (Cystatin C-based calculation of creatinine clearance)
Measured: during hospitalization for the index event
Cardiac autonomic function: Deceleration capacity of heart rate
Measured: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Heart rate variability
Measured: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Periodic repolarization dynamics
Measured: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Baroreflex sensitivity
Measured: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Skin sympathetic nerve activity
Measured: 5 ± 2 days, 4 months, 12 months post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Apr 2021
- Primary completion28 Jan 2026
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian J Reinstadler, MD, PhD, Principal investigator, University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939805
- Sponsor's protocol ID
- 20210121-2475
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reinstadler SJ, Kronbichler A, Reindl M, Tiller C, Holzknecht M, Oberhollenzer F, Kaser A, Gauckler P, Stiermaier T, Feistritzer HJ, Mayr A, Gizewski ER, Rezar R, Bugger H, Eller K, Eitel I, Schneider S, Mayer G, Thiele H, Bauer A, Metzler B, Lechner I; CRP-STEMI Investigators. Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized CRP-STEMI trial. Am Heart J. 2026 Jan;291:1-9. doi: 10.1016/j.ahj.2025.07.067. Epub 2025 Jul 28.
PubMed 40738310
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04939805
- Acronym / sponsor ID
- 20210121-2475
- Keywords
- Cardiac magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 25 Jun 2021 (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.
Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.
Objective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.
Design: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.
Innovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective CRP apheresis as an adjunct to standard of care | Experimental | Device: Selective CRP apheresis using the PentraSorb®-CRP systemApheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI. |
| Standard of care according to current guideline recommendations | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
- Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
- CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
- Eligible for primary PCI
- Age ≥18 years
Key exclusion criteria (12 listed)
- Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
- Persistent hemodynamic instability (Killip class >2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
- The patient is febrile (temperature >38°C) or has experienced an acute infection with fever in the last 14 days.
- CRP >15 mg/l at time of hospital admission.
- Chronic inflammatory disease.
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 |
|---|---|---|
| Selective CRP apheresis using the PentraSorb®-CRP systemSelective CRP apheresis as an adjunct to standard of care. Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI. | Device | Selective CRP apheresis as an adjunct to standard of care |
Primary outcome
Primary efficacy endpoint
Time frame: 5 ± 2 days post PCI
Infarct size expressed as % of left ventricular myocardial mass (LVMM) as visualized by cardiac magnetic resonance (CMR) imaging at 5 ± 2 days post PCI
16 secondary outcomes
Safety endpoint
Time frame: during hospitalization for the index event
All-cause mortality or hospitalization for heart failure within 12 months after randomization
Time frame: within 12 months after randomization
CMR endpoints defined as: Left ventricular ejection fraction and microvascular obstruction and exploratory (intramyocardial hemorrhage, edema extent, myocardial salvage, native T1 mapping, strain)
Time frame: at baseline, 4 months and 12 months after PCI for STEMI
Hospitalization for heart failure within 12 months after randomization
Time frame: within 12 months after randomization
Cardiovascular mortality at 12 months
Time frame: within 12 months after randomization
CRP concentrations
Time frame: during hospitalization for the index event
Left ventricular thrombus formation
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Biomarker concentrations of myocardial necrosis (enzymatic infarct size; high-sensitivity troponin T)
Time frame: at baseline, 4 months, 12 months post PCI
Biomarker concentrations of hemodynamic stress (N-terminal pro-B-Type Natriuretic Peptide)
Time frame: at baseline, 4 months, 12 months post PCI
Renal function (eGFR)
Time frame: during hospitalization for the index event
Renal function (Cystatin C-based calculation of creatinine clearance)
Time frame: during hospitalization for the index event
Cardiac autonomic function: Deceleration capacity of heart rate
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Heart rate variability
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Periodic repolarization dynamics
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Baroreflex sensitivity
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Skin sympathetic nerve activity
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
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 7 Oct 2026.
- Derived from this study: PubMed 40738310Reinstadler SJ, Kronbichler A, Reindl M, Tiller C, Holzknecht M, Oberhollenzer F, Kaser A, Gauckler P, Stiermaier T, Feistritzer HJ, Mayr A, Gizewski ER, Rezar R, Bugger H, Eller K, Eitel I, Schneider S, Mayer G, Thiele H, Bauer A, Metzler B, Lechner I; CRP-STEMI Investigators. Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized CRP-STEMI trial. Am Heart J. 2026 Jan;291:1-9. doi: 10.1016/j.ahj.2025.07.067. Epub 2025 Jul 28.
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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 principal investigator
University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective CRP apheresis using the PentraSorb®-CRP system in people with ST Elevation Myocardial Infarction and C-Reactive Protein, run by Medical University Innsbruck at 5 sites in 2 countries.
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 6 inclusion and 12 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 7 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 5 sites in Austria, Germany. 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 Sebastian J Reinstadler, MD, PhD (+43 (0) 512 504 25665, sebastian.reinstadler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint (time frame: 5 ± 2 days post PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939805, which also lists 1 linked publication.
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 7 Oct 2026.