Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Withdrawn before enrolling

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

In brief

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.

Key facts

Study ID

NCT01809730

Run by

NYU Langone Health

People needed

0

Starts

2012-05-01

Expected to finish

2020-01-01

Last updated by the study team

2015-11-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • ≥ 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

You may not qualify if…

• • Severe co-morbid condition with life expectancy < 6 months
• Inability to give informed consent or adhere to follow-up as per protocol

Where it is running

• NYU Hospital for Joint Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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