Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

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.

Study Overview

• Status: Withdrawn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

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • NYU Hospital for Joint Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This pilot, observational study is designed to identify and follow orthopedic surgical patients meeting specific high-risk criteria for postoperative cardiovascular events. All normal standard of care will be maintained. Patients will be observed from Pre-Admission Testing (PAT) visit through hospital discharge.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiovascular risk; patients with CV disease

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Atherosclerosis; Coronary Disease; Peripheral Vascular Diseases; Coronary Artery Disease; Vascular Diseases; Peripheral Arterial Disease; Renal Insufficiency
• Other Study ID Numbers: S12-02513