Acute Coronary Syndrome Clinical Trial
Official title:
AngelMed for Early Recognition and Treatment of STEMI
A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery. There is no differential intervention administered to the two arms of the ALERTS Study. The study evaluates whether or not a patient alarm from the Guardian System will provide benefit (e.g. shorten pre-hospital delay) compared to symptoms-only ER presentation in the event of a heart attack. An amendment to the data analysis protocol was collaboratively created by AngelMed and FDA, and was adopted by AngelMed on 4/22/2017.
There are over one million acute myocardial infarctions (AMI) each year in the United States
with more than 400,000 of these resulting in death. Early identification of AMI, and prompt
treatment has been shown to significantly improve clinical outcomes. Experimental and
clinical studies have shown that most of the irreversible damage to the myocardium occurs
during the first two hours after coronary occlusion. Milavetz et al. demonstrated that
successful reperfusion therapy within two hours was associated with the greatest degree of
myocardial salvage. According to Boersma, et al., restoration of flow, regardless of the
method used, can abort infarction within the first 30 minutes after coronary occlusion, and
the benefit of fibrinolytic therapy compared with placebo is considerably higher in patients
treated within 2 hours after symptom onset than in those treated later.2 Further, evidence
exists that expeditious restoration of flow in the obstructed infarct artery after the onset
of symptoms in patients with the most severe type of MI, ST elevation MI (STEMI) is a key
determinant of short and long-term outcomes regardless of whether reperfusion is accomplished
by fibrinolysis or percutaneous coronary intervention (PCI). Therefore, the early arrival at
the hospital for a reliable diagnosis and initiation of treatment is paramount to improve the
outcomes of myocardial infarction. However, despite efforts at educating the public over the
past decade, the mean time from AMI symptom onset to arrival at a hospital for treatment has
remained, disappointingly, at 2.5-3.0 hours.
The largest proportion of the total pre-hospital delay is the interval between the onset of
symptoms and the decision to seek medical treatment. Finnegan et al. described that the
reasons for delay in seeking medical evaluation generally stem from patient misconceptions
about symptom experience, expectations, and attribution. In many cases, patients expect the
type of heart attack that they often see in movies or on television: the kind of crushing
chest pain that drops a person to the ground. The reality is that many heart attacks are much
"quieter," causing only mild chest pain or discomfort or other symptoms such as shortness of
breath or diaphoresis.
If patients would take action during the first hour following symptom onset, many lives and
significant cost could be saved. It is technically possible to monitor EKGs and detect an
acute infarction, even if the patient is unaware that he or she is experiencing a heart
attack. However, currently available systems have limitations in the home environment. Twelve
lead EKG systems require a clinically trained individual to place them. Holter monitors
suffer from limitations in the ability to detect ST deviation due to low compliance and are
limited in practice to 24 to 72 hours of monitoring. Systems using surface leads are all
subject to noise and other artifacts from patient movement and body orientation, particularly
if the patient is ambulatory.
A potentially ideal solution is to implant a device that measures heart signals from inside
the heart and will alert the patient when it detects electrogram characteristics set by the
physician as worthy of medical evaluation.
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