Clinical event adjudication: Unstable angina requiring hospitalization

For the list of clinical event adjudication definitions, click here Editors-in-Chief: C. Michael Gibson, M.S., M.D. [mailto:mgibson@perfuse.org]

This chapter presents unstable angina requiring hospitalization definitions used in the Clinical Event Committee adjudication processes. These definitions are current as of 3/26/10.

=Unstable angina requiring hospitalization= Unstable angina requiring hospitalization is defined as:
 * 1) Symptoms of myocardial ischemia at rest (chest pain or equivalent) or an accelerating pattern of angina with frequent episodes associated with progressively decreased exercise capacity AND
 * 2) Prompting an unscheduled visit to a healthcare facility and hospitalization (including chest pain observation units) within 24 hours of the most recent symptoms AND
 * 3) At least one of the following:
 * a. New or worsening ST or T wave changes on resting ECG
 * ST elevation New ST elevation at the J point in two anatomically contiguous leads with the cut-off points: ≥ 0.2 mV in men (> 0.25 mV in men < 40 years) or ≥ 0.15 mV in women in leads V2-V3 and/or ≥ 0.1 mV in other leads.
 * ST depression and T-wave changes New horizontal or down-sloping ST depression ≥ 0.05 mV in two contiguous leads; and/or new T inversion ≥ 0.1 mV in two contiguous leads.
 * The above ECG criteria illustrate patterns consistent with myocardial ischemia. It is recognized that lesser ECG abnormalities may represent an ischemic response and may be accepted under the category of abnormal ECG findings.
 * b. Definite evidence of myocardial ischemia on myocardial scintigraphy (clear reversible perfusion defect), stress echocardiography (reversible wall motion abnormality), or MRI (myocardial perfusion deficit under pharmacologic stress) that is believed to be responsible for the myocardial ischemic symptoms/signs
 * c. Angiographic evidence of ≥ 70% lesion and/or thrombus in an epicardial coronary artery that is believed to be responsible for the myocardial ischemic symptoms/signs
 * d. Need for coronary revascularization procedure (PCI or CABG) during the same hospital stay. This criterion would be fulfilled if the admission for myocardial ischemia led to transfer to another institution for the revascularization procedure without interceding home discharge  AND
 * 4. No evidence of acute myocardial infarction

General Considerations

 * 1) Escalation of pharmacotherapy for ischemia, such as intravenous nitrates or increasing dosages of β-blockers, should be considered supportive of the diagnosis of unstable angina. However, a typical presentation and admission to the hospital with escalation of pharmacotherapy, without any of the additional findings listed under category 3, would be insufficient alone to support classification as hospitalization for unstable angina.
 * 2) If subjects are admitted with suspected unstable angina, and subsequent testing reveals a non-cardiac or non-ischemic etiology, this event should not be recorded as hospitalization for unstable angina. Potential ischemic events meeting the criteria for myocardial infarction should not be adjudicated as unstable angina.
 * 3) Planned rehospitalization for performance of an elective revascularization in the absence of symptoms at rest prompting admission should not be considered a hospitalization for unstable angina. For example, a patient with stable exertional angina whose admission for coronary angiography and PCI is prompted by a positive outpatient stress test should not be considered a hospitalization for unstable angina.
 * 4) A patient who undergoes an elective catheterization where incidental coronary artery disease is found and who subsequently undergoes coronary revascularization will not be considered as meeting the hospitalization for unstable angina endpoint.