Journal of electrocardiology
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In patients with ST-elevation myocardial infarction, fast initiation of reperfusion therapy is mandatory. It is well established that prehospital diagnosis results in earlier initiation of fibrinolysis, but there is limited evidence concerning the value of prehospital evaluation in patients treated with primary percutaneous coronary intervention (PCI). ⋯ In this setting, continuous real-time 1-lead ECG transmission from ambulance to hospital may allow physicians to support ambulance personnel in the treatment of arrhythmias during transportation; and (4) equipment used for prehospital ECG acquisition and transmission has built-in features for continuous ST-segment monitoring. It is hypothesized that continuous ST-segment monitoring performed in the prehospital phase and during primary PCI may provide important prognostic information, with the potential of triaging future pharmacological and interventional treatment at time of PCI.
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Although there are rising public expectations about the prospects for new therapies based on advances in biomedical discoveries, the rate of new product submissions to the Food and Drug Administration (FDA) has not been increasing. Alarmingly, over the past 6 years, there has been a 30% decline in submissions. The reasons for this are multifactorial and include new science not at its full potential, mergers/business arrangements have decreased candidates, chronic disease is harder to study, the failure rate has not improved, and rapidly escalating costs and complexity. ⋯ The partnership is designed to expand product opportunities by sharing existing knowledge and data, allowing the development of enabling standards, to improve drug development and approval. A central tenant of Critical Path is a focus on the evaluative science of the drug approval process, including both efficacy and safety measures. The FDA Electrocardiogram Warehouse is 1 example where a government resource could be used by a confluence of groups to improve the science surrounding important components of the drug approval process such as cardiac safety evaluation.