Phase 3
N=72
Metoprolol to Reduce Perioperative Myocardial Injury
Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03138603 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury — 9; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metoprolol Tartrate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of Beta-blocker Therapy Reducing Post-operative Myocardial Injury |
9; 11 | — |
| SECONDARY Effectiveness in Reduction of Major Adverse Cardiac Events (MACE) |
0; 0 | — |
| SECONDARY Monitor Post-operative Myocardial Ischemia |
0; 0 | — |
| SECONDARY Number of Stroke Related Events Following Surgery |
0; 0 | — |
| SECONDARY Number of Participants Having Vasopressor Therapy to Regulate Symptomatic Hypotension |
0; 0 | — |
| SECONDARY Number of Participant Incidence of Clinically Relevant Bradycardia |
0; 1 | — |
| SECONDARY Participants Number of Days Spent Post-operative Hospitalization |
2.5; 2.5; 2; 3 | — |
| SECONDARY Patient Recovery Progress Events at 30-days Post-operative. |
0; 0 | — |
| SECONDARY Participant Post-operative Mortality at 1-year Following Surgery |
0; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Age >= 50 years
- Beta-blocker naïve [30 days prior to surgery]
- Previously diagnosed coronary artery disease (CAD), or
- History of peripheral vascular disease (PVD), or
- Chronic kidney disease (CKD) [eGFR ≤60ml/min], or
- History of positive stress test or
- 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
- Major non-cardiac, elective surgery under general anesthesia
Exclusion Criteria
Subjects will not be enrolled if any of the following criteria exist:
- History of stroke, or transient ischemic attack (TIA)
- Previously diagnosed carotid disease, i.e., either 70% unilateral or 50% bilateral carotid occlusion.
- Heart rate <=55bpm
- Congestive heart failure with New York Heart Association(NYHA) Functional Classification of III-IV or left ventricular heart failure with ejection fraction ≤50%
- Severe valvular regurgitation
- Second or third degree atrioventricular (AV) block without pacemaker
- Active asthma or chronic obstructive pulmonary disease (COPD) with symptoms or resolving symptoms on day of surgery
- Anemia [HB<=9g/dL]
- Allergy to beta-blockade drugs
- Unwilling or unable to give consent for participation
- Undergoing any carotid endarterectomy, endovascular, endoscopic, superficial, or ambulatory procedures
- Pregnancy or lactating women
- Prisoners
Data sourced from ClinicalTrials.gov (NCT03138603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.