Status:
TERMINATED
Risk Factor Control Before Orthopedic Surgery
Lead Sponsor:
NYU Langone Health
Conditions:
Osteoarthritis
Cardiovascular Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 stra...
Eligibility Criteria
Inclusion
- • ≥ 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
- • 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01837069
Start Date
February 1 2014
End Date
April 2 2018
Last Update
July 27 2020
Active Locations (1)
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1
NYU Hospital for Joint Diseases
New York, New York, United States, 10003