Post hoc labeling an acute ECG as ischemic or non-ischemic based on clinical data: A necessary challenge.

The ECG is crucial in the prehospital (and early inhospital) phase of patients with symptoms suggestive of myocardial ischemia. Therefore, new algorithms for ECG-based myocardial ischemia detection are continuously being researched. Development and validation of these algorithms require a database of acute ECGs (from the prehospital or emergency department setting) including a representative mix of cases (ischemia present) and controls (no ischemia present). Therefore, for every patient in this mix, the "truth" regarding the actual presence or absence of myocardial ischemia during the recording of the acute ECG has to be determined to compare the newly developed algorithm against. This post hoc adjudication process of determining whether an acute (either prehospitally acquired or acquired in the emergency department) ECG was made under ischemic conditions should use all available clinical data (the clinical diagnosis, cardiac imaging data, and laboratory values) of the subsequent patient's admission. Even with all data at hand, post hoc labeling a patient and their acute ECG as a myocardial ischemia case or control cannot be forced into a binary division between definite cases and definite controls. More specifically, to be used for the development of a new algorithm, the patients' ECG has to be scored for the presence or absence of myocardial ischemia at the exact moment of its recording, which renders the classification even more difficult. For instance, even though it may be plausible that myocardial ischemia was present at a given moment during the patient's admission, this is not necessarily proof that the prehospital (or early inhospital) ECG was also made in ischemic conditions: ischemia can be a fluctuating process (as is, e.g., the case in unstable angina pectoris). Therefore, post hoc classification of an acute ECG in terms of the absence or presence of ischemia requires a multipoint scale ranging between definite ischemic to definite non-ischemic, for instance using a 5-point scale (presumed non-ischemic, probably non-ischemic, uncertain, probably ischemic, presumed ischemic). To summarize, the post hoc adjudication process of ECGs of ambulance (and emergency department) patients cannot result in a binary division into definite cases and controls (i.e., patients with or without myocardial ischemia during the recording of the acute ECG), as myocardial ischemia is often dynamic rather than constant. ECGs could be labeled on a multi-point scale, in which the label represents the probability of the actual presence (or absence) of myocardial ischemia at the exact moment of the recording of that ECG. Further development of algorithms for myocardial ischemia detection should consider this concept.