Risk Factor Control Before Orthopedic Surgery (OPTMIZE-OS)

NYU Langone Health

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis; Cardiovascular Disease

Treatments: Drug: Metoprolol; Drug: Lisinopril; Behavioral: Lifestyle counseling; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01837069

12-02407

Details and patient eligibility

About

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

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle counseling

Drug: Atorvastatin

Drug: Lisinopril

Drug: Metoprolol

Control

No Intervention group

Description:

Standard of care