Risk Factor Control Before Orthopedic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Jeffrey Berger, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01837069
First received: April 12, 2013
Last updated: February 13, 2014
Last verified: February 2014

April 12, 2013
February 13, 2014
February 2014
January 2016   (final data collection date for primary outcome measure)
Composite of cardiovascular events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Reduction of a composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, or venous thromboembolism
Same as current
Complete list of historical versions of study NCT01837069 on ClinicalTrials.gov Archive Site
Modified composite of cardiovascular events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation
Same as current
  • Length of stay [ Time Frame: In-Hospital ] [ Designated as safety issue: Yes ]
  • Each Individual Endpoint of the composite of cardiovascular events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • composite of cardiovascular events [ Time Frame: long-term (out to 3-years) ] [ Designated as safety issue: Yes ]
    composite of myocardial infarction, coronary revascularization, stroke, transient ischemic attack or death
  • Length of stay [ Time Frame: In-Hospital ] [ Designated as safety issue: Yes ]
  • Each Individual Endpoint of the composite of cardiovascular events [ Time Frame: 30 days ]
  • Major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • composite of cardiovascular events [ Time Frame: long-term (out to 3-years) ]
    composite of myocardial infarction, coronary revascularization, stroke, transient ischemic attack or death
 
Risk Factor Control Before Orthopedic Surgery
OPTMIZE-OS: Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Osteoarthritis
  • Cardiovascular Disease
  • Drug: Metoprolol
    25mg PO BID if the HR is elevated at preadmission testing
    Other Name: Beta blocker
  • Drug: Lisinopril
    2.5mg PO QD if the HR is elevated at preadmission testing
    Other Name: ACE inhibitor
  • Drug: Atorvastatin
    80mg PO QD at preadmission testing
    Other Name: Statin
  • Behavioral: Lifestyle counseling
    Diet, exercise, medication adherance and smoking counseling
  • Active Comparator: Treatment
    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
    Interventions:
    • Drug: Metoprolol
    • Drug: Lisinopril
    • Drug: Atorvastatin
    • Behavioral: Lifestyle counseling
  • No Intervention: Control
    Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
January 2018
January 2016   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Germaine Cuff, BSN MPH PhD 212-598-6074 germaine.cuff@nyumc.org
United States
 
NCT01837069
OPTIMIZE-OS
Yes
Jeffrey Berger, New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Jeffrey Berger, MD NYU School of Medicine
New York University School of Medicine
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP