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
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Cardiovascular Disease
Drug: Metoprolol
Drug: Lisinopril
Drug: Atorvastatin
Behavioral: Lifestyle counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: OPTMIZE-OS: Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 550
Study Start Date: February 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
No Intervention: Control
Standard of care

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837069

Contacts
Contact: Germaine Cuff, BSN MPH PhD 212-598-6074 germaine.cuff@nyumc.org

Locations
United States, New York
NYU Hospital for Joint Diseases Recruiting
New York, New York, United States, 10003
Contact: Germaine Cuff, BSN MPH PHD    212-598-6074    germaine.cuff@nyumc.org   
Principal Investigator: Mitchell Marshall, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jeffrey Berger, MD NYU School of Medicine
  More Information

No publications provided

Responsible Party: Jeffrey Berger, Assistant Professor of Medicine (Cardiology and Hematology), Assistant Professor of Surgery (Vascular Surgery), Director of Cardiovascular Thrombosis, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01837069     History of Changes
Other Study ID Numbers: OPTIMIZE-OS
Study First Received: April 12, 2013
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Hypertension
Diabetes
Coronary Artery Disease
Peripheral Vascular Disease

Additional relevant MeSH terms:
Osteoarthritis
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Atorvastatin
Lisinopril
Metoprolol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014