Testing the feasibility of operationalizing a prospective, randomized trial with remote cardiac safety EKG monitoring during a pandemic

Abstract

Background The coronavirus SARS-CoV-2 is highly contagious. Hydroxychloroquine (HCQ) has in vitro activity against SARS-CoV-2. The FDA authorized emergency use of HCQ against COVID-19. HCQ may have dose-related cardiotoxicity. This clinical trial received ethical approval on May 15, 2020, operationalized in June to evaluate a low prophylaxis dose of HCQ (200mg BID) in household contacts of COVID-19-positive patients without physical contact between investigators and participants. It represents the first report of the FDA approved 6-lead EKGs with a smartphone KardiaMobile® 6L application. Methods To reach a sample size of 170, household members were contacted by telephone, emailed consent forms with electronic signature capability, and randomized 2:1 to HCQ or observation for 10 days with follow-up of 14 days. Home saliva PCR tests recorded COVID status on days 1 and 14. Symptoms and 6-lead EKGs were obtained daily. Results Fifty-one participants were randomized with 42 evaluable at day 14. Remote monitoring of 407 EKGs revealed no QTc prolongation or other ECG changes in either group. At time of consent, no participants were symptomatic or COVID+. On days 1 and 14, COVID tests were positive in 4 and 2 in the HCQ group and 4 and 0 in the observation group. No tests converted to positive. There were no deaths or hospitalizations. Conclusions A clinical trial without personal contact, rapidly initiated and operationalized to exclude cardiac toxicity using daily remote 6-lead EKG monitoring, is feasible. Of 407 EKGs from 42 participants, there was no evidence of cardiac toxicity. Clinical trial registration Clinicaltrials.gov : NCT04652648 registration date: December 3, 2020

Detecting early physiologic changes through cardiac implantable electronic device data among patients with COVID-19

“…The early detection capabilities of machine learning algorithms leveraging data from CIEDs (such as HeartLogic Index) may also be extended to identify other types of non-heart failure-related decompensation, such as influenza or pneumonia infections, among high-risk groups. Thus, while CIEDs have traditionally been used for cardiac monitoring, including during the pandemic to reduce exposure associated with avoidable in-person cardiac care, 4 , 5 , 16 , 17 this study suggests CIEDs may also be used for surveillance and early detection of other forms of acute decompensation, including but not limited to COVID-19. The ability to follow a high-risk cohort of cardiac patients remotely and receive alerts when they may be in the early stages of an infection may significantly improve clinicians’ early intervention abilities in clinical care.…”

Systematic review and meta-analysis of randomized trials of hydroxychloroquine for the prevention of COVID-19

“…gov, the absence of published results. Of the remaining 13 reports, two were excluded because they found no incident events in the HCQ arm [17] or at all [18] (Supplementary Fig. 1 contains the PRISMA 2020 flow diagram).…”

“…Table 1 summarizes the key design characteristics and effect estimates reported by each study. The primary outcome definition varied across trials, with some trials using the presence of symptoms with or without laboratory confirmation [4,19,23], others using laboratory-confirmed symptomatic COVID-19 [5,17,18,24,25,27] and others laboratory-confirmed SARS-CoV-2 infection with or without symptoms [20,21,26]. Our risk of bias assessment identified the handling of incomplete ascertainment of the outcome and the exclusion of patients after randomization as possible sources of moderate bias (see Supplementary Table 1).…”

Diagnostic quality electrocardiogram from a HeartMate 3 supported patient using a smartphone-based recording device

“…Although use of these devices has not been previously described for LVAD patients, mobile ECG devices have been shown to reduce the number of cardiacrelated Emergency Department visits, both in patients with previous arrhythmic episodes 8 and in healthy patients. 9 There have been previous attempts to improve the quality of ECG recordings in LVAD patients by applying a low-pass filter to a value below the frequency peak by the LVAD and a speed-specific bandstop filter to remove the LVAD frequency peak. These, however, are not always able to eliminate all artefact, as the LVAD pump reverberates at multiple frequencies above and below the principal oscillation frequency that cannot be removed by the filters.…”

“…Although use of these devices has not been previously described for LVAD patients, mobile ECG devices have been shown to reduce the number of cardiac-related Emergency Department visits, both in patients with previous arrhythmic episodes 8 and in healthy patients. 9…”