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no participants enrolled
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiovascular risk | patients with CV disease |
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| 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 |
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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:
Exclusion Criteria:
• Severe co-morbid condition with life expectancy < 6 months
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This pilot, observational study is designed to identify and follow orthopedic surgical patients meeting specific high-risk criteria for postoperative cardiovascular events. All normal standard of care will be maintained. Patients will be observed from Pre-Admission Testing (PAT) visit through hospital discharge.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Hospital for Joint Diseases | New York | New York | 10003 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058729 | Peripheral Arterial Disease |
| D051437 | Renal Insufficiency |
| D003920 | Diabetes Mellitus |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006973 | Hypertension |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |