CRP Apheresis in STEMI

Launched by MEDICAL UNIVERSITY INNSBRUCK · Jun 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CRP apheresis to see if it can help reduce heart damage in patients who have just experienced a type of heart attack known as STEMI (ST-Elevation Myocardial Infarction). When someone has a STEMI, they can suffer from a significant amount of heart tissue damage, which can lead to further heart problems in the future. The trial aims to find out if removing a substance called C-reactive protein (CRP) from the blood can help protect the heart and improve recovery after standard treatment, which includes a procedure called primary PCI to open blocked arteries.

To participate in this trial, individuals must be at least 18 years old and have experienced their first acute STEMI within the last 12 hours. They also need to have a certain level of CRP in their blood after the procedure. However, people with certain conditions, like previous heart attacks or serious infections, cannot join. Participants will receive the standard treatment plus the CRP apheresis and will be monitored closely to see how well this new approach works. This is an important study because it could lead to better treatments for heart attack patients in the future.

Gender

ALL

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