Using CRP apheresis to treat heart attacks

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 study investigates the effectiveness of selective C-reactive protein (CRP) apheresis as an additional treatment for patients experiencing acute ST-elevation myocardial infarction (STEMI) who are undergoing primary percutaneous coronary intervention (PCI). The aim is to reduce the size of the heart muscle damage caused by the heart attack by targeting inflammation mediated by CRP. Patients will be randomly assigned to receive either the CRP apheresis treatment or standard care, with outcomes assessed by masked evaluators. The study is designed to provide insights into how reducing CRP levels may improve heart recovery and patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
2. Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
3. CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
4. Eligible for primary PCI
5. Age ≥18 years
6. Written informed consent

Exclusion Criteria:

1. Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
2. Persistent hemodynamic instability (Killip class \>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
3. The patient is febrile (temperature \>38°C) or has experienced an acute infection with fever in the last 14 days.
4. CRP \>15 mg/l at time of hospital admission.
5. Chronic inflammatory disease.
6. Known history of severe hepatic failure
7. Chronic kidney disease with a creatinine clearance \<30ml/min./1.73m²
8. Contraindication to CMR.
9. Pre-STEMI life expectancy of \<1 year
10. Participation in another interventional trial
11. Limited possibility to join the follow-up examinations (e.g. patient lives abroad)
12. Pregnancy

Where it's running

• University Clinic for Cardiology and Nephrology, Medical University of Graz
  Graz, Austria Recruiting
• University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology.
  Innsbruck, Austria Recruiting
• Leipzig Heart Center
  Leipzig, Germany Recruiting
• University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg
  Salzburg, Austria Not yet recruiting
• Medical Clinic II - University Heart Center Lübeck
  Lübeck, Schleswig-Holstein, Germany Not yet recruiting

Study contacts

• Principal investigator: Sebastian J Reinstadler, MD, PhD — University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck
• Study coordinator: Sebastian J Reinstadler, MD, PhD
• Email: sebastian.reinstadler@gmail.com
• Phone: +43 (0) 512 504 25665

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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.