Myocardial Infarction Clinical Trial
Official title:
Pilot Study to Test Feasibility, Safety, Molecular Mediators and Preliminary Efficacy of Remote Myocardial Postconditioning Provided With Extrinsic Cuff Compression of Lower Limb During Primary PCI
Background: Experimental studies suggest that remote limb ischaemic postconditioning
(RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the
beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia
in healthy volunteers and in patients with stable coronary artery disease.
Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the
setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators
of its effects.
Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the
onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in
a single-blind fashion. All patients receive therapy according to the current international
guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a
cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion.
RemPostCon is started at the time of angioplasty in the infarct related artery. Primary
endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac
magnetic resonance (CMR) is performed early before discharge and 4 months after the event,
if there are no contraindications.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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