Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

NYU Langone Health

Status: Withdrawn

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

Study type: Observational

Funder types: Other

Identifiers

NCT01809730

S12-02513

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Cardiovascular risk

Description:

patients with CV disease