Clinical Study Report - Calidad de Información CFR

2) NSTEMI
corresponding R wave amplitude, or both in two or more contiguous leads or reelevation
in ST segment > 0.1 mV.
① MI occurs during hospitalization and satisfies one of the following criteria:
- CK-MB > 3 times the upper limit of normal value and increase of >50 % in the
second sample over the first sample when two samples are collected at two
different times.
- New Q wave on the EKG of > 0.04 second duration or a depth > one-fourth of the
corresponding R wave amplitude, or both in two or more contiguous leads or ST
segment elevation > 0.1 mV.
② MI occurs following the discharge from hospital and satisfies one of the following
criteria:
- CK-MB > 2 times the upper limit of normal value
- New Q wave on the EKG of > 0.04 second duration or a depth > one-fourth of the
corresponding R wave amplitude, or both in two or more contiguous leads or ST
segment elevation > 0.1 mV.
(3) Emergency Revascularization
1) The second PCI after removing the guidewire while still in the catheterization laboratory
was considered as the primary outcome. The return to the catheterization laboratory
for emergency revascularization to treat recurrent ischemia was also considered as the
primary outcome. A scheduled PCI (staged procedures) was not considered as the
primary outcome.
2) The coronary artery bypass graft to treat ischemia following the failed PCI was
considered as the primary outcome. The elective surgery to treat pre-existing multi-vessel
disease was not considered as the primary outcome.
Secondary efficacy measurement assessed
New change in electrocardiogram was decided by investigator’s decision about the ECG result.
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