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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease; Osteoarthritis
• Intervention / Treatment: Drug: Metoprolol; Drug: Lisinopril; Drug: Atorvastatin; Behavioral: Lifestyle counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • NYU Hospital for Joint Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
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	Drug: Metoprolol; 25mg PO BID if the HR is elevated at preadmission testing; Other Names: Beta blocker; Drug: Lisinopril; 2.5mg PO QD if the HR is elevated at preadmission testing; Other Names: ACE inhibitor; Drug: Atorvastatin; 80mg PO QD at preadmission testing; Other Names: Statin; Behavioral: Lifestyle counseling; Diet, exercise, medication adherance and smoking counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Composite of Cardiovascular Events	the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation	30 days

Other Outcome Measures

Outcome Measure	Time Frame
Length of Stay	Hospital stay, ~7 days
Each Individual Endpoint of the Composite of Cardiovascular Events	30 days

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jeffrey Berger, MD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 2, 2018
• Study Completion (Actual): April 2, 2018

Study Registration Dates

• First Submitted: April 12, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 22, 2013

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Hypertension; Coronary Artery Disease; Peripheral Vascular Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Protective Agents; Cardiotonic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Atorvastatin; Metoprolol; Lisinopril; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: 12-02407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No