About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Selective CRP Apheresis plus Standard of CareExperimental treatment 2 interventions

Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

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.

Time frame

66 ± 8 hours after randomization

Secondary outcomes

1

Major adverse cardiovascular events (MACE)

Composite endpoint of cardiovascular death, non-fatal myocardial infarction, or re-admission for heart failure.

Time frame

30 days

2

All-cause mortality

Death from any cause within 30 days after randomization.

Time frame

30 days

3

Cardiovascular mortality

Death due to cardiovascular causes within 30 days after randomization.

Time frame

30 days

4

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.

Time frame

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

CRP Apheresis in Infarct-Related Cardiogenic Shock

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts