CRP Apheresis for infarct-related cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigator-initiated, multicenter pilot trial randomizes adults with infarct-related cardiogenic shock to standard therapy alone or with selective CRP apheresis using PentraSorb-CRP. Up to three apheresis sessions are given within about five hours of randomization and repeated per protocol. The main outcome is the CLIP score at about 66 hours after randomization, with secondary endpoints including mortality, cardiovascular events, inflammation and organ-function biomarkers, and safety outcomes. The study is conducted in Germany and Austria and aims to see if removing CRP can improve short-term risk and outcomes in this high-risk population.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Prof. Dr. med. Holger Thiele Thiele — Heart Center Leipzig at University of Leipzig
• Study coordinator: CRP-SHOCK Leipzig Heart Science gGmbH
• Email: CRP-SHOCK@leipzig-heart.de
• Phone: +49 341 865 251556

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.