Myocardial Infarction Clinical Trial
Official title:
Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
Study objectives: To assess the effects of postconditioning on infarct size in patients with
ST-elevation infarction referred to PCI.
Study design: Prospective, randomized, open-label study with blinded endpoint evaluation.
Included patients will be randomly allocated to postconditioning or control. Patients with
symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG
criteria for primary PCI are eligible. PCI follow established routines. In postconditioning
patients, additional, short (1 min), intermittent balloon occlusions will be applied after
initial opening of infarct related artery. After this intervention, PCI proceeds routinely
with stent implantation. In the control group, stent implantation after initial opening
proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months.
260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.
Clinical implications: Reperfusion therapy, administered as early as possible after start of
symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still,
however, many patients suffer large infarctions, subsequently with an increased risk of
heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has
been shown to reduce infarct size and thus potentially improve prognosis. However, the
effect of postconditioning must be confirmed in larger clinical trials before implemented in
routine treatment.
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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