Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of these two interventions may improve clinical outcome after STEMI remains unknown. The objective of the present study is to determine whether combination of ICIC and RIC can improve STEMI patients clinical outcome at 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
750
RIC: Four cycles of \[5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation\] started as soon as possible prior to PCI reperfusion. At least one full cycle (inflation + deflation) has to be completed before PCI reperfusion. ICIC: Four cycles of \[1 min balloon inflation followed by 1 min balloon deflation\] started as soon as possible after reopening of the culprit coronary artery (maximum within 3 minutes after reflow). The balloon will be placed carefully above the culprit lesion so as to minimize potential micro-embolization.
Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.
Algemeen Ziekenhuis Sint Jan
Bruges, Belgium
CHU de Charleroi
Charleroi, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Hopital Louis Pradel
Bron, France
Combined incidence of [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months after MI, large infarct defined as CK peak at 6 hours > 4500 UI/L]
Time frame: 6 months
Cardiovascular death at 6 months.
Time frame: 6 months
Worsening of heart failure
Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.
Time frame: 6 months
Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]
Time frame: 6 months
Major Adverse Cardiac Events (MACE)
MACE at 6 months: \[all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure; malignant ventricular arrhythmias; recurrent infarction; unstable angina; unplanned revascularization; stroke\].
Time frame: 6 months
Renal failure
Renal failure (+25% increase in serum creatinine at 6 months versus baseline).
Time frame: 6 months
Peak of creatine kinase
Time frame: 4-6 hours post-PCI
creatine kinase
Time frame: 5 days
Measure hsCRP
Time frame: 5 days
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Rate of CRP
Time frame: 5 days