|AliveCor's AliveECG App--Courtesy of AliveCor|
Utah's Intermountain Health Care is leading an initiative to simultaneously test emergency room chest pain patients with two encephalograms, a standard 12-lead one, and a modified version of Fierce 15 member AliveCor's Mobile ECG, which connects to the back of a smartphone.
Then, three independent cardiologist will read both ECGs while blinded to the source to determine whether the patient is suffering from a heart attack. They will also read standard and smartphone ECGs of patients on which the heart attack protocol was activated, according to ClinicalTrials.Gov.
Since the changes to AliveCor's mobile ECGs are not FDA cleared, the doctors' diagnoses will not be used for clinical decision making. The goal of the study is to compare their diagnoses to those based on a standard 12-lead ECG, as the company strives to make taking, monitoring, and reviewing ECGs simpler, cheaper and more portable.
AliveCor co-founder and chief medical officer Dr. David Albert told FierceMedicalDevices in an interview that the modifications include a wider signal diagnostic bandwidth comparable to that of a 12-lead ECG, new components to connect the iPhone and attached ECG to lead wires that then connect to disposable electrodes at standard locations on the body, and new analysis software that creates a report.
Unlike traditional 12-lead ECGs, the experimental version of AliveCor's Mobile ECG will contain two leads, same as the commercially available product. "It uses two electrodes to measure 9 leads, calculating (as does the 12-lead ECG) the other 3 leads. The two electrodes are moved to different positions and the software on the smartphone 'stitches; them all together," AliveCor spokeswoman Rebecca Phillips explained in an email to FierceMedicalDevices.
About 50 patients will enroll at Intermountain Health Care hospitals to participate in the study to "assess the operational feasibility of using the Smartphone to obtain '12-lead equivalent' ECG recordings in patients suspected to have STEMI (a fancy acronym for heart attack), and determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies," ClinicalTrials.Gov says. Intermountain Health Care aims to use the study to develop an Institutional Review Board approved protocol and statistical analysis that compares utility of the iPhone ECG to a standard 12-lead ECG for the diagnosis of heart attack.
Albert said that the current trial will consist of several hundred patients from various institutions. He said the trial will be used to inform future studies of the potential new application of its flagship mobile ECG device, and that when it is ready, the company intends to file for 510(k) clearance from the FDA to get permission to use the modified device clinically.
The Intermountain trial is expected to last from August to November, and the primary outcome will be the level of agreement in diagnosis (heart attack or no heart attack) between standard and iPhone readings. ClinicalTrials.Gov says that efforts will be made to enroll 1 STEMI patient for every 2 non-STEMI patients.
MobiHealthNews points out that Intermountain Health previously experimented with the Mobile ECG, and concluded in a December study of 6 patients that "the smartphone ECG had excellent correlation with the gold standard 12-lead ECG in all patients," and said that the technology can improve the speed and availability of electrocardiographic evaluation.
The nonprofit owns and operates about 25 hospitals in Utah, according to its website.
Diagnosis of heart attack would mark a new use of the MobileECG, and the potentially lifesaving application would signal confidence in the technology's accuracy. It is currently used in non-emergency settings to diagnose and monitor atrial fibrillation, a warning sign of stroke, based on a 30-second measurement of the pulse through the fingertips.
Last month the company added two features to its commercially available AliveECG App, which can now measure fluctuations in heartbeat and contains a log for tracking daily activities, symptoms and events in real-time.
Special Report: FierceMedicalDevices' 2014 Fierce 15 - AliveCor
Editor's Note: This article has been updated with additional information from AliveCor chief medical officer Dr. David Albert and spokeswoman Rebecca Phillips.