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Selective depletion of C-reactive protein by therapeutic apheresis (CRP-apheresis) in acute myocardial infarction

Selective depletion of C-reactive protein by therapeutic apheresis (CRP-apheresis) in acute myocardial infarction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008988
Enrollment
80
Registered
2015-08-06
Start date
2015-11-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I21

Interventions

Group 1: 40 patients will receive 2 treatments with an interval of 24 ± 12 hours (after start of the previous treatment). The first treatment starts 10 - 36 hours after the onset of symptoms of myocar

Sponsors

Pentracor GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Size of the infarcted area, determined by MRI, 5 ± 3 days as well as 12 ± 2 weeks after myocardial infarction.

Secondary

MeasureTime 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

Public ContactBurghard Thiesen

Pentracor GmbH

thiesen@pentracor.de+49 (0)3302 209449-35

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 15, 2026