CRP Apheresis in Infarct-Related Cardiogenic Shock

NCT07687017 | Not Yet Recruiting

• 1 other identifier: CRP-SHOCK Trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiogenic Shock; Acute Myocardial Infarction (AMI)

Keywords

C-reactive protein; CRP apheresis; Selective CRP apheresis; Inflammation; Infarct-related cardiogenic shock; Acute myocardial infarction; CLIP score; PentraSorb-CRP; Pilot study; Multicenter study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Major adverse cardiovascular events (MACE)

  30 days

• All-cause mortality

  30 days

• Cardiovascular mortality

  30 days

• CLIP score over time

  18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization

• Individual components of the CLIP score

  18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization

Study Arms (2)

Selective CRP Apheresis plus Standard of Care

EXPERIMENTAL

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); Other: Standard of care

Standard of Care

ACTIVE COMPARATOR

Participants receive guideline-directed standard of care for infarct-related cardiogenic shock without CRP apheresis.

Other: Standard of care

Interventions

Selective C-reactive protein apheresis (PentraSorb®-CRP) DEVICE

Selective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care.

Also known as: CRP Apheresis plus Standard of Care

Selective CRP Apheresis plus Standard of Care

Standard of care OTHER

Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.

Selective CRP Apheresis plus Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leipzig Heart Science gGmbH: lead
• Helios Health Institute GmbH: collaborator
• Heart Center Leipzig at University of Leipzig: collaborator

Study Sites (1)

Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, 04289, Germany

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22920912 BACKGROUND

• 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.

  PMID: 29083953 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Inflammation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Prof. Dr. med. Holger Thiele Thiele

  Heart Center Leipzig at University of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CRP-SHOCK Leipzig Heart Science gGmbH

CONTACT

+49 341 865 251556; CRP-SHOCK@leipzig-heart.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to receive either standard of care alone or standard of care plus selective C-reactive protein (CRP) apheresis. Randomization is performed centrally using a computerized system. Participants remain in their assigned treatment group throughout the study.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: July 7, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)