Using CRP apheresis to treat heart attacks

Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction

This study is testing if a treatment that removes a specific protein from the blood can help heart attack patients recover better when combined with standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Medical University Innsbruck (Academic / other)
• Locations: 5 sites (Graz and 4 other locations)
• Trial ID: NCT04939805 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are experiencing their first acute STEMI and have elevated CRP levels after primary PCI.

Not a fit: Patients with a history of prior myocardial infarction or those with chronic inflammatory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce heart damage and improve recovery outcomes for patients with STEMI.

How similar studies have performed: While the approach of using CRP apheresis is novel, similar studies targeting inflammation in myocardial infarction have shown promising results.

Eligibility criteria

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 this trial is running

Graz and 4 other locations

• 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)
• 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)
• Leipzig Heart Center — Leipzig, Germany (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

Conditions ST Elevation Myocardial Infarction; C-Reactive Protein; Apheresis; Myocardial Injury; Cardiac magnetic resonance imaging