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Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01809730
Recruitment Status : Withdrawn (no participants enrolled)
First Posted : March 13, 2013
Last Update Posted : November 17, 2015
Information provided by (Responsible Party):
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.

Condition or disease
Coronary Artery Disease Cerebral Vascular Disease Peripheral Artery Disease Renal Insufficiency Diabetes COPD Hypertension Active Smoker Cancer CHF 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
Study Start Date : May 2012
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Cardiovascular risk
patients with CV disease

Primary Outcome Measures :
  1. Cardiac ischemia/necrosis [ Time Frame: 30 days ]
  2. Venous thromboembolism [ Time Frame: 30 days ]
  3. Pulmonary embolism [ Time Frame: 30 dyas ]
  4. Myocardial infarction [ Time Frame: 30 Days ]
  5. Cerebral vascular event [ Time Frame: 30 days ]
  6. Death [ Time Frame: 30 days ]
  7. Transient ischemic attack [ Time Frame: 30 days ]
  8. Surgical site infection [ Time Frame: 30 days ]
  9. Delayed wound healing [ Time Frame: 30 days ]
  10. Clinically relevant bleeding [ Time Frame: 30 days ]
  11. Transfusion within 48 hours post-op [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01809730

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United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
Sponsors and Collaborators
NYU Langone Health
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Responsible Party: NYU Langone Health Identifier: NCT01809730    
Other Study ID Numbers: S12-02513
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Renal Insufficiency
Coronary Artery Disease
Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arterial Occlusive Diseases
Kidney Diseases
Urologic Diseases
Peripheral Vascular Diseases