Risk Factor Control Before Orthopedic Surgery
Overview[ - collapse ][ - ]
| Purpose | This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery. |
|---|---|
| Condition | Osteoarthritis Cardiovascular Disease |
| Intervention | Drug: Metoprolol Drug: Lisinopril Drug: Atorvastatin Behavioral: Lifestyle counseling |
| Phase | Phase 4 |
| Sponsor | New York University School of Medicine |
| Responsible Party | New York University School of Medicine |
| ClinicalTrials.gov Identifier | NCT01837069 |
| First Received | April 12, 2013 |
| Last Updated | February 13, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 12, 2013 |
|---|---|
| Last Updated Date | February 13, 2014 |
| Start Date | February 2014 |
| Estimated Primary Completion Date | January 2018 |
| Current 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 |
| Current 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 |
Descriptive Information[ + expand ][ + ]
| Brief Title | Risk Factor Control Before Orthopedic Surgery |
|---|---|
| Official Title | OPTMIZE-OS: Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery |
| Brief Summary | This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery. |
| 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 |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: Metoprolol 25mg PO BID if the HR is elevated at preadmission testing Other Names: Beta blockerDrug: Lisinopril 2.5mg PO QD if the HR is elevated at preadmission testing Other Names: ACE inhibitorDrug: Atorvastatin 80mg PO QD at preadmission testing Other Names: StatinBehavioral: Lifestyle counseling Diet, exercise, medication adherance and smoking counseling |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 550 |
| Estimated Completion Date | January 2018 |
| Estimated Primary Completion Date | January 2016 |
| Eligibility 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 |
| Gender | Both |
| Ages | 21 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Germaine Cuff, BSN MPH PhD 212-598-6074 germaine.cuff@nyumc.org |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01837069 |
|---|---|
| Other Study ID Numbers | OPTIMIZE-OS |
| Has Data Monitoring Committee | Yes |
| Information Provided By | New York University School of Medicine |
| Study Sponsor | New York University School of Medicine |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jeffrey Berger, MD NYU School of Medicine |
| Verification Date | February 2014 |
Locations[ + expand ][ + ]
| NYU Hospital for Joint Diseases | New York, New York, United States, 10003 Contact: Germaine Cuff, BSN MPH PHD | 212-598-6074 | germaine.cuff@nyumc.orgPrincipal Investigator: Mitchell Marshall, MD Recruiting |
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