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WithdrawnNot applicableNCT01809730
Official study title

Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forCoronary Artery Disease · Cerebral Vascular Disease

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 17, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?NYU Langone Health

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
NYU Langone Health
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion criteria
  • Severe co-morbid condition with life expectancy \< 6 months
  • Inability to give informed consent or adhere to follow-up as per protocol

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • NYU Hospital for Joint DiseasesNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 17, 2015. Always confirm current availability with the study team.

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