CRP Apheresis in Infarct-Related Cardiogenic Shock (CRP-SHOCK)

Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)

Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.

The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.

The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiogenic Shock; Acute Myocardial Infarction (AMI)
• Intervention / Treatment: Device: Selective C-reactive protein apheresis (PentraSorb®-CRP); Other: Standard of care

Detailed Description

Cardiogenic shock following acute myocardial infarction is associated with a high inflammatory response and mortality rates of approximately 40-50% despite early revascularization and intensive care treatment. Experimental and clinical evidence suggests that elevated C-reactive protein (CRP) contributes to myocardial injury, impaired tissue regeneration, and adverse outcomes.

The CRP-SHOCK trial investigates whether selective removal of circulating CRP by apheresis improves short-term risk stratification and clinical outcomes in patients with infarct-related cardiogenic shock. The intervention consists of up to three CRP apheresis sessions initiated within 5 ± 1 hours after randomization and repeated at predefined intervals using the PentraSorb®-CRP system.

The primary efficacy endpoint is the CLIP score at 66 ± 8 hours after randomization. Secondary endpoints include mortality, major adverse cardiovascular events, biomarkers of inflammation and organ function, and safety outcomes such as bleeding, stroke, and infections. The trial is conducted as a multicenter pilot study in Germany and Austria.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CRP-SHOCK Leipzig Heart Science gGmbH; Phone Number: +49 341 865 251556; Email: CRP-SHOCK@leipzig-heart.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Heart Center Leipzig at University of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).
• Cardiogenic shock defined as:
• Systolic blood pressure <90 mmHg for >30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and
• Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output <30 mL/hour, Arterial lactate >2 mmol/L
• C-reactive protein (CRP) level ≥7 mg/L at baseline.
• Age ≥18 years.
• Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.

Exclusion Criteria:

• Fever (body temperature >38°C) or acute infection with fever within the last 14 days.
• Chronic inflammatory disease.
• Known history of severe hepatic failure.
• Chronic kidney disease with creatinine clearance <30 mL/min/1.73 m² prior to hospital admission.
• Life expectancy <12 months prior to cardiogenic shock.
• Participation in another interventional clinical trial.
• Pregnancy.
• Resuscitation duration >30 minutes.
• Cardiogenic shock due to causes other than acute myocardial infarction.
• Onset of cardiogenic shock >12 hours before randomization.
• Age >80 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective CRP Apheresis plus Standard of Care; Participants receive standard of care for infarct-related cardiogenic shock plus selective C-reactive protein (CRP) apheresis using the PentraSorb®-CRP system. CRP apheresis is initiated within 5 ± 1 hours after randomization and repeated at 30 ± 4 hours and 54 ± 6 hours after randomization.	Device: Selective C-reactive protein apheresis (PentraSorb®-CRP); Selective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care.; Other Names: CRP Apheresis plus Standard of Care; Other: Standard of care; Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.
Active Comparator: Standard of Care; Participants receive guideline-directed standard of care for infarct-related cardiogenic shock without CRP apheresis.	Other: Standard of care; Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLIP score	The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide [NT-proBNP] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.	66 ± 8 hours after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events (MACE)	Composite endpoint of cardiovascular death, non-fatal myocardial infarction, or re-admission for heart failure.	30 days
All-cause mortality	Death from any cause within 30 days after randomization.	30 days
Cardiovascular mortality	Death due to cardiovascular causes within 30 days after randomization.	30 days
CLIP score over time	The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide [NT-proBNP] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.	18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
Individual components of the CLIP score	The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide [NT-proBNP] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.	18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
C-reactive protein (CRP) concentration	Serum CRP concentrations measured before and after CRP apheresis sessions.	9 ± 1 hours, 34 ± 4 hours, 58 ± 6 hours, and 66 ± 8 hours after randomization
Peak NT-proBNP concentration	Maximum NT-proBNP serum concentration recorded during the index hospital stay.	During index hospitalization
Peak serum creatinine concentration	Maximum serum creatinine concentration recorded during the index hospital stay.	During index hospitalization
Cardiac power index	The Cardiac Power Index (CPI) is a continuous hemodynamic measurement reflecting the rate of cardiac energy output indexed to body surface area, calculated as cardiac index × mean arterial pressure × a constant (W/m²). It is not a score on a defined scale but a continuous physiological parameter without fixed minimum or maximum values. Normal values are generally reported in the range of 0.5-0.7 W/m². Lower CPI values are associated with worse outcomes, including higher mortality, need for cardiac transplantation, or ventricular assist device placement - thus, higher values indicate better cardiac performance.	18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization
Time to hemodynamic stabilization	Time from randomization to sustained hemodynamic stabilization as defined by the treating physician.	hospital discharge
Duration of catecholamine therapy	Total duration of vasopressor and inotropic support.	hospital discharge
Length of intensive care unit stay	Number of days spent in the intensive care unit.	hospital discharge
Length of hospital stay	Total length of hospital stay in days.	hospital discharge

Collaborators and Investigators

• Sponsor: Leipzig Heart Science gGmbH
• Collaborators: Heart Center Leipzig at University of Leipzig; Helios Health Institute GmbH
• Investigators: Principal Investigator: Prof. Dr. med. Holger Thiele Thiele, Heart Center Leipzig at University of Leipzig

Publications and helpful links

General Publications

• Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
• Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.
• Pöss J, Köster J, Fuernau G, et al. Risk stratification for patients in cardiogenic shock after acute myocardial infarction. European Heart Journal. 2017;38:386-396.
• Slagman A, Searle J, Müller C, et al. C-reactive protein apheresis in acute myocardial infarction: results of the CAMI-1 study. Clinical Research in Cardiology. 2021;110:1597-1606.

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; C-reactive protein; Pilot study; Acute myocardial infarction; Multicenter study; CRP apheresis; Selective CRP apheresis; Infarct-related cardiogenic shock; CLIP score; PentraSorb-CRP
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Inflammation; Shock, Cardiogenic; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: CRP-SHOCK Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly. Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No