Metoprolol to Reduce Perioperative Myocardial Injury
- Registration Number
- NCT03138603
- Lead Sponsor
- University of Chicago
- Brief Summary
The purpose of this research study is to test if a commonly used, FDA-approved medication, called metoprolol, given at the conclusion of anesthesia following surgery, and during postoperative admission, reduces the possibility of heart related complications in patients with coronary artery disease (CAD).
- Detailed Description
All enrolled patients will be beta-blocker naïve for at least 30-days prior to their scheduled surgical procedure. Study patients will be randomly assigned to an interventional drug arm (metoprolol tartrate vs placebo-comparator). At the conclusion of anesthesia following the surgical procedure, patients hemodynamically stable and meeting study safety parameters (heart rate greater-than-65; systolic blood pressure greater-than-110) will receive 3-intravenous doses of interventional study drug (metoprolol tartrate 5mg or placebo-comparator), based on previously assigned study arm; then, patients remaining hemodynamically stable will receive an oral dose (25mg metoprolol vs placebo-comparator) approximately every 8-hours for up to 3-days during postoperative hospital admission.
From arrival in the preop holding area through up to 72 hours postoperative admission to hospital discharge or end of study treatment (whichever occurs first), patients will be continuously monitored through medical records assessments, Holter monitoring, mobile hemodynamic monitoring (VisiMobile), and in-person daily follow-up visits that include 12-lead ECG, and blood collections for serial cardiac biomarkers for high-sensitivity troponin.
Additional study patient postoperative assessment will be performed at 30 days and 1 year after surgery. These can be completed by interview and/or medical record review.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metoprolol Metoprolol Tartrate Metoprolol group, 3-intravenous doses of 5mg metoprolol tartrate (over 15-minutes), and oral dose(s) of 25mg metoprolol approximately every 8 hours postoperatively for up to 3-days (or 72 hrs). Placebo Placebo Placebo comparator group, up-to-three intravenous doses of placebo comparator (over 15-minutes), and oral dose(s) of a placebo comparator approximately every 8 hours postoperatively for up to 3-days (or 72 hrs).
- Primary Outcome Measures
Name Time Method Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury 0-3 days, following surgery Measured effectiveness of post-operative beta-blocker therapy to reduce myocardial injury by monitoring daily biomarkers (High-Sensitivity cardiac Troponin \[HS-cTn\]).
Daily post-operative biomarker (hs-cTn) measurements to determine myocardial injury.
Myocardial injury is defined as a new hscTn elevation \>99th percentile, or a 50% increase if the baseline hscTn is already elevated \>99th percentile
- Secondary Outcome Measures
Name Time Method Effectiveness in Reduction of Major Adverse Cardiac Events (MACE) 0-3 days, following surgery MACE are defined as myocardial ischemia (MI), cardiac death or coronary revascularization
Monitor Post-operative Myocardial Ischemia 0-3 days, following surgery Post-operative cardiac monitoring via ECG to evaluate if myocardial ischemia is present.
Myocardial Ischemia is defined as ST depression or elevation of ≥0.2 mV in one lead or ≥0.1 mV in two contiguous leads lasting ≥10 minNumber of Stroke Related Events Following Surgery 0-3 days, following surgery Stroke will be defined as focal or global cerebral, spinal, or retinal dysfunction of sudden onset
Number of Participants Having Vasopressor Therapy to Regulate Symptomatic Hypotension 0-3 days, following surgery Monitor participants with vasopressor requirements for blood pressure regulation due to symptomatic hypotension (rate/duration time).
Symptomatic hypotension (systolic BP \< 90 mmHg) can be determined by clinical intervention due to low blood pressure and/or patient developed clinical symptoms due to hypotension.Number of Participant Incidence of Clinically Relevant Bradycardia 0-3 days, following surgery Monitored participants with cumulative events of bradycardia (rate/duration time).
Bradycardia is defined as low heart rate (HR \< 50/min).Participants Number of Days Spent Post-operative Hospitalization 0-3 days following surgery Measurement of participants number of days spent hospitalized (0-3 days) following surgery.
Patient Recovery Progress Events at 30-days Post-operative. 30-days from surgery Measured number of participant post-operative recovery events, 30-days following the surgical procedure.
Participant Post-operative Mortality at 1-year Following Surgery 1-Year from surgery Measured number of patient post-operative mortality at 1-year.
Measured by 'living', 'deceased', 'date of death'.
Trial Locations
- Locations (2)
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States