I21
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • STEMI as defined by the guidelines of the European Society of Cardiology (ESC) for the treatment of AMI in patients with ST-segment elevation. • TIMI III flow after PCI (stent implantation) • Killip-Class = II • 2 - 12 h from onset of symptoms until coronary reperfusion • Informed consent • Legal competence
Exclusion criteria
Exclusion criteria: • Previous myocardial infarction • Acute infectious disease (body temperature (auricular, sublingual) > 38.0 °C) • Systolic blood pressure < 100 mmHg • Known hypersensitivity to therapeutic apheresis • Cardiogenic shock • Dialysis dependent renal insufficiency • Previous coronary artery bypass surgery • Contraindication for MRI (e.g. non-MRI-capable implants, claustrophobia) • Malignant or chronic inflammatory disease • Pregnancy or lactation period • Limited possibility to join the follow-up examination (e.g., patient lives abroad) • Participation in other interventional trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of the infarcted area, determined by MRI, 5 ± 3 days as well as 12 ± 2 weeks after myocardial infarction. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of expected and unexpected adverse effects of the CRP-apheresis • LVEF (left ventricular ejection fraction), determined by MRI of the heart 5 ± 3 days as well as 12 ± 2 weeks after the infarction. • Major adverse cardiac events (MACE) 6 and 12 months after the infarction. MACEs are defined as follows: death from any cause, non-fatal re-infarction or stroke, unstable angina pectoris, congestive heart failure leading to inpatient treatment and coronary revascularization (percutaneous coronary angioplasty or coronary artery bypass). The time until occurance of the first event is regarded as end point. | — |
Countries
Germany
Contacts
Pentracor GmbH