Risk Factor Control Before Orthopedic Surgery

Phase 4TerminatedNCT01837069

NYU Langone Health198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

198

Conditions

Osteoarthritis Cardiovascular Disease

Interventions

MetoprololDRUG

25mg PO BID if the HR is elevated at preadmission testing

LisinoprilDRUG

2.5mg PO QD if the HR is elevated at preadmission testing

AtorvastatinDRUG

80mg PO QD at preadmission testing

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Hospital for Joint Diseases

New York, New York, United States

Outcomes

Primary Outcomes

Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism

Time frame: 30 days

Secondary Outcomes

Modified Composite of Cardiovascular Events

the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation

Time frame: 30 days

Data from ClinicalTrials.gov

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