Patient cardiac safety
Case study
Putting patient cardiac safety first through at-home monitoring
Challenge
While medications are being developed every day that show great promise to improve disease symptoms, pharmaceutical companies cannot bring them to market unless they “first, do no harm.” Negative cardiac effects are especially concerning in drug testing, as they can be difficult to uncover through just a few days of in-clinic patient monitoring.
A digital health lead at a large pharmaceutical company came to ICON Outcome Measures, with this exact challenge, concerned about the development of cardiac abnormalities in patients treated with one of their therapeutics. Patients would show normal cardiac function in initial assessments, only to return to the clinic at a later visit with cardiac abnormalities. The pharmaceutical team needed to better understand what was happening between those check-ins.
Solution
The team wanted to find a wearable that could capture continuous cardiac rhythms and be used to detect QT prolongation, an issue with the heart muscle taking a longer time to contract and relax than is normal.
They were looking for passive and continuous monitoring with the goal of establishing when these abnormalities were occurring in the timeframe between initial and the next scheduled patient evaluations.
Outcome
The team used Atlas Reports to zero in on multi-lead ECGs with evidence to identify cardiac arrhythmias, and specifically, QTc prolongation. Atlas evidence confirmed their hypothesis – a single lead ECG would not be sufficient for this measure. They compared products they had previously used (e.g., BodyGuardian, AliveCor, Zio patch) with products with which they were less familiar (e.g., CAM by Bardy Diagnostics, Cor by Peerbridge Health, EPatch by Biotel) to evaluate evidence, tech specs, data rights and security questions side by side. The Atlas platform led the team to make efficient, informed decisions based on all evidence and technology options available.
Continuous cardiac rhythm monitoring is one of 850+ measure categories on the Atlas data platform. Atlas covers 18,000+ measures and more than 3,600+ digital health technologies.