Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery
Overview
- Phase
- Phase 4
- Intervention
- Metoprolol
- Conditions
- Osteoarthritis
- Sponsor
- NYU Langone Health
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.
Detailed Description
OPTIMIZE - OS (Optimization of Pre-surgical Testing with an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events - Orthopedic Surgery) trial is to determine the best management strategy for patients undergoing orthopedic surgery. OPTIMIZE will be a prospective randomized trial that will enroll patients during pre-surgical testing before orthopedic surgery. This trial will investigate different strategies aimed at lowering cardiovascular events following orthopedic surgery. The study will compare an intensive multifactorial intervention comprising behavioral modification and polypharmacologic therapy aimed at several modifiable risk factors versus usual care. The trial hypothesis is that a personalized optimization approach is superior to usual care in reducing a composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism or thrombosis requiring reoperation at 30-days. Secondary endpoints include length of stay, major bleeding, each individual endpoint from the primary endpoint, and quality of life.
Investigators
Eligibility Criteria
Inclusion Criteria
- •• ≥ 21 years of age
- •Subjects undergoing open orthopedic surgery of the hip, knee or spine
- •Surgery is scheduled at least 3 days after PAT visit and no more than 14 days.
- •High risk subject cohort
- •Coronary artery disease, or
- •Cerebrovascular disease (prior stroke, TIA or carotid artery disease (\>70% stenosis), or
- •Peripheral artery disease, or
- •Prior Venous thromboembolism or arterial thromboembolism, or
- •Age ≥ 60 years and 2 of the following
- •Renal insufficiency (creatinine clearance \< 60ml/min)
Exclusion Criteria
- •• Known intolerance to statins
- •Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or rosuvastatin/crestor 40mg daily)
- •Bilateral renal artery stenosis
- •End stage renal disease (receiving dialysis or CrCl \<30ml/min)
- •Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin receptor blocker (e.g. angioedema, hyperkalemia)
- •Known allergy or intolerance to beta blockers
- •Known sick sinus syndrome not treated with permanent pacemaker
- •Known greater than first degree AV block not treated with a pacemaker
- •Excessive alcohol intake
- •Acute Coronary Syndrome requiring hospitalization within 1 month
Arms & Interventions
Treatment
Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated
Intervention: Metoprolol
Treatment
Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated
Intervention: Lisinopril
Treatment
Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated
Intervention: Atorvastatin
Treatment
Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated
Intervention: Lifestyle counseling
Outcomes
Primary Outcomes
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism
Time Frame: 30 days
Secondary Outcomes
- Modified Composite of Cardiovascular Events(30 days)