Utah health system Intermountain Healthcare -- and other, as yet unknown providers -- appear to be investigating AliveCor's smartphone ECG device in a clinical context, to determine whether the iPhone version of the device is comparable with traditional 12-lead ECGs. The trial aims to test the device with 50 patients who have possible ST Elevation Myocardial Infarction (STEMI), a common type of heart attack caused by a blockage of blood supply to the heart.
A posting on Clinical Trials.gov indicates that the full trial will begin data collection in August and complete it in November. Patients presenting to the emergency room or primary care with chest pains, who are being evaluated for STEMI will have their ECG taken with both a smartphone device and a traditional 12-lead ECG. Three independent cardiologists, blinded to the source of each ECG readout, will make assessments based on those readouts.
The goals of the study will be to assess the feasibility of the smartphone device, but it is also apparently part of a larger investigation with other institutions. The posting says the study aims to "determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future IRB-approved protocol and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard."
Although the posting never names AliveCor as the provider of the iPhone ECG, Intermountain and AliveCor conducted a similar study last year with just six patients and indicated that the objective was "to gain experience with smartphone electrocardiography prior to designing a larger multicenter study evaluating standard 12-lead ECG compared to smartphone ECG."
The pilot study, published in December in the Journal of Electrocardiology, concluded that the readings obtained by the AliveCor device were just as acceptable for identifying myocardial infarction as the 12-lead readings.
"These pilot results suggest that a low cost, convenient alternative to existing ECG technology using now common smartphones and other smart electronic devices may extend the availability of ECG beyond its current reach and facilitate the early detection of STEMI (and possibly non-STEMI), including personalized use by the owner or by point-of-care, out-of-hospital first medical contact," the authors, including AliveCor founder Dr. David Albert, wrote in the December paper. "The promise of smart device diagnosis of acute coronary syndromes deserves further evaluation in larger, multi-center studies."
Much of AliveCor's momentum lately has been on the consumer side, with new FDA-cleared algorithms allowing the company to offer customers automatic atrial fibrillation detection and the detection of abnormalities or interference in their ECG. However, the device could also be useful for emergency room physicians, or even paramedics and first responders, who could use ECG ratings in the field to respond more quickly to heart attacks.