Metoprolol to Reduce Perioperative Myocardial Injury

University of Chicago72 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Heart Diseases

Interventions

Metoprolol TartrateDRUG

Patients will be randomly assigned to receive up-to-three intravenous doses of 5mg metoprolol tartrate (over 15-minutes) at the end of their surgical procedure, and a scheduled oral dose regimen of 25mg metoprolol approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).

PlaceboDRUG

Patients will be randomly assigned to receive up-to-three intravenous doses of a placebo-comparator (over 15-minutes) at the end of their surgical procedure, and scheduled oral dose regimen of a placebo-comparator approximately every 8-hours postoperatively for up to 3-days (or 72 hrs).

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Age \>= 50 years 2. Beta-blocker naïve \[30 days prior to surgery\] 3. Previously diagnosed coronary artery disease (CAD), or 1. History of peripheral vascular disease (PVD), or 2. Chronic kidney disease (CKD) \[eGFR ≤60ml/min\], or 3. History of positive stress test or 4. At high risk for CAD (must meet at least 2 criteria): i. Age \>= 70 years ii. Hypertension iii. Diabetes requiring oral medication or insulin iv. Current smoker or some days smoker within the past 2 years 4. Major non-cardiac, elective surgery under general anesthesia Exclusion Criteria Subjects will not be enrolled if any of the following criteria exist: 1. History of stroke, or transient ischemic attack (TIA) 2. Previously diagnosed carotid disease, i.e., either 70% unilateral or 50% bilateral carotid occlusion. 3. Heart rate \<=55bpm 4. Congestive heart failure with New York Heart Association(NYHA) Functional Classification of III-IV or left ventricular heart failure with ejection fraction ≤50% 5. Severe valvular regurgitation 6. Second or third degree atrioventricular (AV) block without pacemaker 7. Active asthma or chronic obstructive pulmonary disease (COPD) with symptoms or resolving symptoms on day of surgery 8. Anemia \[HB\<=9g/dL\] 9. Allergy to beta-blockade drugs 10. Unwilling or unable to give consent for participation 11. Undergoing any carotid endarterectomy, endovascular, endoscopic, superficial, or ambulatory procedures 12. Pregnancy or lactating women 13. Prisoners

Locations (2)

University of Chicago Medicine

Chicago, Illinois, United States

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury

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