Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
| Status: | Withdrawn |
|---|---|
| Conditions: | Cancer, Cancer, Chronic Obstructive Pulmonary Disease, High Blood Pressure (Hypertension), Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2012 |
| End Date: | January 2020 |
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.
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.
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.
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
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