Myocardial Infarction Clinical Trial
Official title:
Prevention of Myocardial Injury by Remote Ischemic Preconditioning in Emergent or Urgent Non-cardiac Surgery: a Randomized Clinical Trial
Worldwide, more than 200 million patients have major non-cardiac surgery annually and a
significant proportion of these patients suffer major cardiovascular complications (e.g.
nonfatal myocardial infarction, cardiac arrest, vascular death) within 30 days of their
surgery. Perioperative myocardial infarction is the most common cardiovascular complication
and recent clinical studies have shown that even minor myocardial injury in relation to
non-cardiac surgery is associated with 30-day mortality.
Remote ischemic preconditioning is a procedure, which protects remote tissues and organs e.g.
against ischemia-reperfusion injury. Cycles of forearm or leg ischemia and reperfusion by the
inflation of a blood-pressure cuff for brief periods are the preferred method.The aim of this
interventional clinical study is to determine whether remote ischemic preconditioning can
reduce markers of myocardial injury in emergent or urgent non-cardiac surgery.
Patients with a hip fracture will be included in the study. The patients will be randomized
to remote ischemic preconditioning or control (no intervention). The remote ischemic
preconditioning procedure is carried out immediately after the induction of regional or
general anesthesia. The blood pressure cuff is placed on the upper limb. The cuff is inflated
to 200 mmHg resulting in a total occlusion of the blood flow to the limb. After 5 minutes of
ischemia the cuff is deflated and the limb is reperfused for 5 minutes. The procedure is
carried out 4 times in a row. For patients with systolic blood pressures >185 mmHg, the cuff
will be inflated to at least 15 mmHg above the patient's systolic blood pressure.
The primary outcome is myocardial injury in noncardiac surgery within day 4 postoperatively.
We expect 15% of the patients in the placebo group to suffer myocardial injury while the
incidence of myocardial injury is expected to be reduced to 7% in the intervention group.
Type I error is set at 5% and type II error is set at 20%. In total 2 x 264 patients need to
be included based on this power calculation. We will include patients until we have a total
of 2 x 270 patients for evaluation (per-protocol).
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