Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiovascular risk

patients with CV disease

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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NYU Hospital for Joint Diseases

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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S12-02513

Identifier Type: -

Identifier Source: org_study_id