Risk Factor Control Before Orthopedic Surgery

Osteoarthritis Clinical Trial

— OPTMIZE-OS  

Official title:

Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01837069
• Other study ID #: 12-02407
• Status: Terminated
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: April 2, 2018

Study information

• Verified date: July 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 198
• Est. completion date: April 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Osteoarthritis

Intervention

Drug:
• Metoprolol
25mg PO BID if the HR is elevated at preadmission testing
• Lisinopril
2.5mg PO QD if the HR is elevated at preadmission testing
• Atorvastatin
80mg PO QD at preadmission testing

Behavioral:
• Lifestyle counseling
Diet, exercise, medication adherance and smoking counseling

Locations

Country	Name	City	State
United States	NYU Hospital for Joint Diseases	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Stay		Hospital stay, ~7 days
Other	Each Individual Endpoint of the Composite of Cardiovascular Events		30 days
Primary	Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism		30 days
Secondary	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