Risk Factor Control Before Orthopedic Surgery
Condition: Osteoarthritis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Metoprolol; Lisinopril; Atorvastatin; Lifestyle counseling
Intervention description: 25mg PO BID if the HR is elevated at preadmission testing; 2.5mg PO QD if the HR is elevated at preadmission testing; 80mg PO QD at preadmission testing; Diet, exercise, medication adherance and smoking counseling
Intervention MeSH terms: Metoprolol; Lisinopril; Atorvastatin; Angiotensin-Converting Enzyme Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Hypertension; Diabetes; Coronary Artery Disease; Peripheral Vascular Disease

Summary:

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

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)

               -  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