Risk Factor Control Before Orthopedic Surgery

Study Overview
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Brief Summary
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This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.

Detailed Description
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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.

Official Title
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Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery

Conditions
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Osteoarthritis, Cardiovascular Disease

Intervention / Treatment
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* Drug: Metoprolol
* Drug: Lisinopril
* Drug: Atorvastatin
* Behavioral: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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) Diabetes COPD Hypertension Active smoker or stopped less than 30 days prior to consent Cancer (excluding BCC) Heart Failure 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 Stroke within 1 month Known pregnancy Severe co-morbid condition with life expectancy < 6 months Inability to give informed consent or adhere to follow-up as per protocol Current participation in another investigational drug or device trial

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>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 | Drug: Metoprolol<br>* 25mg PO BID if the HR is elevated at preadmission testing<br>* Other names: Beta blocker;Drug: Lisinopril<br>* 2.5mg PO QD if the HR is elevated at preadmission testing<br>* Other names: ACE inhibitor;Drug: Atorvastatin<br>* 80mg PO QD at preadmission testing<br>* Other names: Statin;Behavioral: Lifestyle counseling<br>* Diet, exercise, medication adherance and smoking counseling<br>|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Composite of Cardiovascular Events | the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Diabetes, Coronary Artery Disease, Peripheral Vascular Disease