Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Withdrawn

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

• Registration Number: NCT01809730
• Lead Sponsor: NYU Langone Health

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 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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically relevant bleeding	30 days
Transfusion within 48 hours post-op	30 days
Death	30 days
Cardiac ischemia/necrosis	30 days
Pulmonary embolism	30 dyas
Cerebral vascular event	30 days
Transient ischemic attack	30 days
Surgical site infection	30 days
Venous thromboembolism	30 days
Myocardial infarction	30 Days
Delayed wound healing	30 days

Trial Locations

Locations (1)

NYU Hospital for Joint Diseases; 🇺🇸 New York, New York, United States