CRP Apheresis in STEMI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMedical University Innsbruck
About this trial
Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.
Objective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.
Design: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.
Innovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
Eligible for primary PCI
Disqualifiers
Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
Persistent hemodynamic instability (Killip class >2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
The patient is febrile (temperature >38°C) or has experienced an acute infection with fever in the last 14 days.
CRP >15 mg/l at time of hospital admission.
Trial design
Design model
Parallel
Treatments tested in this trial
Selective CRP apheresis using the PentraSorb®-CRP system
DeviceSelective CRP apheresis as an adjunct to standard of care. Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
Treatment groups
202 Participants
are divided into 2 treatment groupsGroup A: Selective CRP apheresis as an adjunct to standard of careExperimental treatment 1 intervention
Group B: Standard of care according to current guideline recommendationsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary efficacy endpoint
Infarct size expressed as % of left ventricular myocardial mass (LVMM) as visualized by cardiac magnetic resonance (CMR) imaging at 5 ± 2 days post PCI
Time frame
5 ± 2 days post PCISecondary outcomes
1
Safety endpoint
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) during hospitalization for the index event
Time frame
during hospitalization for the index event2
All-cause mortality or hospitalization for heart failure within 12 months after randomization
All-cause mortality or hospitalization for heart failure within 12 months after randomization (endpoint of interest with respect to the two-stage adaptive design)
Time frame
within 12 months after randomization3
CMR endpoints defined as: Left ventricular ejection fraction and microvascular obstruction and exploratory (intramyocardial hemorrhage, edema extent, myocardial salvage, native T1 mapping, strain)
CMR endpoints will be assessed at baseline, 4 and 12 months CMR follow-up study and are defined according to the Journal of American College of Cardiology Scientific Expert Consensus document.
Time frame
at baseline, 4 months and 12 months after PCI for STEMI4
Hospitalization for heart failure within 12 months after randomization
Time frame
within 12 months after randomizationSponsors and contacts
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Source ClinicalTrials.gov