Metoprolol to Reduce Perioperative Myocardial Injury

Summary

Participation Requirements

Description

All patients will be beta-blocker naïve for at least 30 days prior to surgery and be randomized 1:1 to receive metoprolol tartrate or placebo. Patients will receive up to 3 IV doses of study drug (placebo or IV metoprolol tartrate 5mg) prior to extubation, and subsequently an oral dose (placebo or 2...

All patients will be beta-blocker naïve for at least 30 days prior to surgery and be randomized 1:1 to receive metoprolol tartrate or placebo. Patients will receive up to 3 IV doses of study drug (placebo or IV metoprolol tartrate 5mg) prior to extubation, and subsequently an oral dose (placebo or 25mg metoprolol tartrate) in the PACU, and then oral dosing at approx. every 8 hours thereafter through postop day 3 (72 hrs). From arrival in the preop holding area through up to 72 hours postop or end of study treatment (whichever occurs first), patients will be continuously monitored with Holter ECG, a mobile hemodynamic monitor (VisiMobile), daily follow-up visits to include 12-lead ECG, and blood collections for serial cardiac biomarkers for high-sensitivity troponin. In addition to the previously-mentioned suite of wireless monitors, we propose to apply two physiologic monitors that focus on the patient's autonomic state. These two measurements are non-invasive and potentially will enable us to better characterize the patient's autonomic response at critical timepoints. Additional benefits of these monitors include their possible correlation with pain and stress, and their potential as key elements in future Mobile Health (mHealth)-based studies and therapies. The first of the enhanced monitors uses an off-the-shelf wristband fitness tracker (e.g., Fitbit) for collection of heart rate, and from these data, derives the patient's heart rate variability (HRV). HRV is a dynamic measure of the number and type of distinct frequencies that exist within the subject's overall heart beat pattern, and can be related to both cardiovagal tone and numerous affective states. There is some evidence that the acute response to pain correlates with HRV. Additionally, HRV has been found to have decreased high-frequency components in patients with chronic pain. Our HRV collection and analysis would use the technology underlying the Mindset app, (but not the app itself) to stream the heart rate data to a secured tablet and perform the heart rate variability analysis., The Mindset app, which itself will not be used by the patient is being utilized in a current IRB-approved study as a potential sensor-assisted e-therapy for PTSD (P.I. Dr. Rumi Price, Ph.D.). This app also allows for the real-time, tablet-based collection of subjective data (e.g., pain and anxiety scores). The second of the monitors uses an ultra-thin, ultra-compliant non-invasive sensor to intermittently measure changes in temperature and blood flow on skin's surface. This highly sensitive device can detect subtle changes in skin blood flow, including those that occur as part of the autonomic response to stressful conditions. The thermal sensors, referred to as epidermal transient plane source (ETPS) sensors, utilize the well-established transient plane source method toward the identification of the thermal characteristics of skin. The ETPS sensor capabilities have been thoroughly studied, and the device concepts have been employed successfully in clinical studies related to blood flow[8], dermatological health[9], thermal transport properties of skin, and wounds. The measures that the ETPS sensors--cutaneous blood flow and temperature-will be analyzed along with HRV responses to identify potential correlations between autonomic tone and the subject's responses to different phases of post-operative recovery. In conjunction with the additional history questions asked of the subject, the subject may also be asked about the presence or absence of previous chronic pain and/or anxiety. At several time points along the course of recovery, the subject may be asked to provide subjective information on his/her pain and anxiety. Data on medication administration (type of medication, dose amount, and time of administration) may also be collected. Follow-up at approximately 30 days and 1 year after surgery.

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