Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Study Overview
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Brief Summary
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This is a non-randomized, non-interventional pilot observational study designed to follow high-risk patients through their surgical and hospital stay. The investigators will collect 2 4ml vial's of blood (total of 8ml) prior to surgery to assess CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

Detailed Description
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This study is primarily an observational pilot study. After identifying patients as high-risk according to the following criteria: CAD and/or CVD and/or PAD and/or >=60 years old and at least 2 of the following - renal insufficiency, diabetes, COPD, hypertension, active smoker (or active within 6 months of consent), cancer, congestive heart failure, or any blood clot - they will be asked to sign a consent form. Patients surgical and hospital course will continue as per standard of care. Prior to surgery, 8ml of blood will be collected for to assess cardiovascular biomarkers including inflammatory, metabolic, hypercoagulable and platelet biomarkers to be tested independently in Dr. Berger's lab in Smilow. Study staff will perform electrocardiograms on POD 2. Results of these ECGs will not be placed in the patients' charts. No other procedures will be done for research purposes only.

Official Title
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Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Conditions
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Coronary Artery Disease, Cerebral Vascular Disease, Peripheral Artery Disease, Renal Insufficiency, Diabetes, COPD, Hypertension, Active Smoker, Cancer, CHF, Prior DVT/PE

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • ≥ 21 years of age Subjects undergoing open orthopedic surgery of the hip, knee or spine High-risk subject cohort: Coronary artery disease (CAD), or Cerebrovascular disease (CVD) (prior stroke, TIA or carotid artery disease (>70% stenosis), or Peripheral artery disease (PAD), or Age ≥ 60 years and any 2 of the following: Renal insufficiency (creatinine clearance < 60ml/min) Diabetes Chronic Obstructive Pulmonary Disease (COPD) Hypertension Active smoker or stopped less than 30 days prior to consent Cancer Congestive heart failure Prior blood clot Exclusion Criteria: • Severe co-morbid condition with life expectancy < 6 months Inability to give informed consent or adhere to follow-up as per protocol

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiovascular risk<br>patients with CV disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac ischemia/necrosis |  | 30 days | 
| Venous thromboembolism |  | 30 days | 
| Pulmonary embolism |  | 30 dyas | 
| Myocardial infarction |  | 30 Days | 
| Cerebral vascular event |  | 30 days | 
| Death |  | 30 days | 
| Transient ischemic attack |  | 30 days | 
| Surgical site infection |  | 30 days | 
| Delayed wound healing |  | 30 days | 
| Clinically relevant bleeding |  | 30 days | 
| Transfusion within 48 hours post-op |  | 30 days |