Cardiovascular Disease, Osteoarthritis
Conditions
Keywords
Hypertension, Diabetes, Coronary Artery Disease, Peripheral Vascular Disease
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.
Interventions
DRUGMetoprolol
25mg PO BID if the HR is elevated at preadmission testing
DRUGLisinopril
2.5mg PO QD if the HR is elevated at preadmission testing
DRUGAtorvastatin
80mg PO QD at preadmission testing
BEHAVIORALLifestyle counseling
Diet, exercise, medication adherance and smoking counseling
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Composite of Cardiovascular Events | 30 days | the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation |
Other
| Measure | Time frame |
|---|---|
| Length of Stay | Hospital stay, ~7 days |
| Each Individual Endpoint of the Composite of Cardiovascular Events | 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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
Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling | 103 |
| Control Standard of care | 95 |
| Total | 198 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 103 Participants | 95 Participants | 198 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants | 12 Participants | 26 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants | 11 Participants | 21 Participants |
| Race/Ethnicity, Customized # Unknown or not reported | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 80 Participants | 74 Participants | 154 Participants |
| Region of Enrollment United States | 103 participants | 95 participants | 198 participants |
| Sex: Female, Male Female | 56 Participants | 44 Participants | 100 Participants |
| Sex: Female, Male Male | 47 Participants | 51 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 95 |
| other Total, other adverse events | 0 / 103 | 0 / 95 |
| serious Total, serious adverse events | 0 / 103 | 0 / 95 |
Outcome results
Primary
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism | 10 participants |
| Control | Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism | 2 participants |
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
Time frame: 30 days
Population: No data are available for this Outcome Measure. Multiple efforts were made to obtain the data from the PI but were unsuccessful, therefore, data cannot be reported.
Other Pre-specified
Each Individual Endpoint of the Composite of Cardiovascular Events
Time frame: 30 days
Population: Efforts were made to collect this data from PI, but data analysis was not completed for this outcome measure
Other Pre-specified
Length of Stay
Time frame: Hospital stay, ~7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Length of Stay | 3 days |
| Control | Length of Stay | 3 days |