Status:
WITHDRAWN
Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
Lead Sponsor:
NYU Langone Health
Conditions:
Coronary Artery Disease
Cerebral Vascular Disease
Eligibility:
All Genders
21+ years
Brief Summary
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 bl...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- • ≥ 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
- • Severe co-morbid condition with life expectancy \< 6 months
- Inability to give informed consent or adhere to follow-up as per protocol
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01809730
Start Date
May 1 2012
End Date
January 1 2020
Last Update
November 17 2015
Active Locations (1)
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1
NYU Hospital for Joint Diseases
New York, New York, United States, 10003