Clinical trial NCT01837069: Risk Factor Control Before Orthopedic Surgery
Official title: Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Cardiovascular Disease
Keywords: Hypertension
Diabetes
Coronary Artery Disease
Peripheral Vascular Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 198
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism
timeFrame: 30 days
Secondary outcomes:
measure: Modified Composite of Cardiovascular Events
timeFrame: 30 days
Other outcomes:
measure: Length of Stay
timeFrame: Hospital stay, ~7 days
measure: Each Individual Endpoint of the Composite of Cardiovascular Events
timeFrame: 30 days
Locations:
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Jeffrey Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: