Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
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ClinicalTrials.gov Identifier: NCT01809730
Recruitment Status :
(no participants enrolled)
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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Layout table for eligibility information
Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
• ≥ 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