2019 IANC/ASNC Research Fellow Discusses Challenges of Conducting a Trial During a Pandemic
One year after receiving the 2019 IANC/ASNC Research Fellowship Award, Senthil Selvaraj, MD, was back on ASNC's stage (this time virtually) to present preliminary findings from the KEETO-CROSS study.Speaking during the ASNC2020 Presidents' Session, Dr. Selvaraj thanked the IANC and ASNC for their research funding and for supporting the careers of early-career investigators.
Senthil Selvaraj, MD, MA
Dr. Selvaraj, now a fourth-year fellow in Penn Medicine's Division of Cardiovascular Medicine, noted the challenges of conducting a randomized clinical trial during a pandemic. “Because of COVID-19, our trial was significantly delayed,” he said. The results presented at ASNC2020 were preliminary, he said, though the study team implemented a variety of strategies to safely move forward with their research.
As outlined in Figure 1, the KEETO-CROSS team developed solutions for protecting their volunteers and themselves, limiting the loss of patients to follow-up, conserving resources made scarce by the pandemic, and barriers to patient enrollment.
“Study recruitment is understandably less robust in the current climate,” Dr. Selvaraj explained. “We have broadened our recruitment considerably to meet our target enrollment.”
Figure 1. Conducting a randomized clinical trial during a pandemic
Source: Selvaraj et al., JAHA, 2020.
At the time of presentation, 20 FDG-PET scans had been performed in nine patients in KEETO-CROSS, which is a randomized, crossover, noninferiority, open-label trial of the ketogenic diet vs. ketone supplementation in healthy volunteers. Patients are being randomized to the ketogenic diet (assessed at 24 and 72 hours) and then, after a washout period, cross over to the study's other arm (exogenous ketone supplementation).
The study is designed to test two hypotheses: (1) whether a ketone supplement will be noninferior to the ketogenic diet in suppressing myocardial glucose uptake; and (2) whether higher beta-hydroxybutyrate (BHB) will be inversely related to FDG activity and whether there is a reliable BHB threshold at which myocardial glucose suppression occurs.
The answers to these questions are important, Dr. Selvaraj said, because “the ketogenic diet inconsistently results in adequate myocardial glucose suppression, which risks false-positive scans, unnecessary immunosuppression, cost, and follow-up testing.”
At ASNC2020, Dr. Selvaraj shared preliminary descriptive statistics and noted that the early analysis suggests that the mode, duration, and level of ketosis are important predictors of myocardial glucose suppression. He added that KEETO-CROSS shows signs of providing “important data regarding optimal modes and levels of ketosis to achieve myocardial glucose suppression.”
Several weeks after his presentation, Dr. Selvaraj shared with ASNC that the trial is nearing completion. He and his grant mentor Paco Bravo, MD, director of Nuclear Cardiology at the Hospital of the University of Pennsylvania, look forward to sharing results with the nuclear cardiology community. Stay tuned to ASNC Flashpoint for updates.
The ASNC/IANC Research Fellowship Award was established to encourage and support careers in nuclear cardiology research while growing the science of cardiac imaging and advancing the specialty. Throughout "Giving December," ASNC is raising funds to support the research fellowship award. You can participate by joining in our "Holiday Hustle" -- an easy, fun way to show your support while competing for prizes.