CRP Apheresis in Infarct-Related Cardiogenic Shock

N/ANot Yet RecruitingNCT07687017

Leipzig Heart Science gGmbH50 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Major adverse cardiovascular events (MACE)

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

Time frame: 30 days

All-cause mortality

Death from any cause within 30 days after randomization.

Time frame: 30 days

Cardiovascular mortality

Death due to cardiovascular causes within 30 days after randomization.

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

Serum CRP concentrations measured before and after CRP apheresis sessions.

Time frame: 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.

Time frame: During index hospitalization

Peak serum creatinine concentration

Maximum serum creatinine concentration recorded during the index hospital stay.

Time frame: 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.

Time frame: 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.

Time frame: hospital discharge

Duration of catecholamine therapy

Total duration of vasopressor and inotropic support.

Time frame: hospital discharge

Length of intensive care unit stay

Number of days spent in the intensive care unit.

Time frame: hospital discharge

Length of hospital stay

Total length of hospital stay in days.

Time frame: hospital discharge

CRP Apheresis in Infarct-Related Cardiogenic Shock

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts