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Not yet recruiting NCT07687017

CRP Apheresis in Infarct-Related Cardiogenic Shock

No phase Interventional Cardiogenic Shock Acute Myocardial Infarction (AMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Selective C-reactive protein apheresis (PentraSorb®-CRP), Standard of care.
Who it may be relevant to
Registry conditions: Cardiogenic Shock, Acute Myocardial Infarction (AMI). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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 Standard of care
    Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.

Primary outcome measures

  • CLIP score [Time frame: 66 ± 8 hours after randomization]
Secondary outcome measures (12)
  • Major adverse cardiovascular events (MACE) [Time frame: 30 days]
  • All-cause mortality [Time frame: 30 days]
  • Cardiovascular mortality [Time frame: 30 days]
  • CLIP score over time [Time frame: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization]
  • Individual components of the CLIP score [Time frame: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization]
  • C-reactive protein (CRP) concentration [Time frame: 9 ± 1 hours, 34 ± 4 hours, 58 ± 6 hours, and 66 ± 8 hours after randomization]
  • Peak NT-proBNP concentration [Time frame: During index hospitalization]
  • Peak serum creatinine concentration [Time frame: During index hospitalization]
  • Cardiac power index [Time frame: 18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization]
  • Time to hemodynamic stabilization [Time frame: hospital discharge]
  • Duration of catecholamine therapy [Time frame: hospital discharge]
  • Length of intensive care unit stay [Time frame: hospital discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Heart Center Leipzig at University of Leipzig — Leipzig

Publications

  • 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.
  • 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 201 PMID 22920912
  • 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 Myo PMID 29083953

Identifiers

NCT: NCT07687017 · CRP-SHOCK Trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗