NCT01809730

Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 blood (total of 8ml) prior to surgery to assess CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

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 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.

Conditions

• Coronary Artery Disease
• Cerebral Vascular Disease
• Peripheral Artery Disease
• Renal Insufficiency
• Diabetes
• COPD
• Hypertension
• Active Smoker
• Cancer
• CHF
• Prior DVT/PE

Timeline

• Start date: 2012-05-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2013-03-13
• Last updated: 2015-11-17

Locations

1 site across 1 country: United States