Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

This study is currently recruiting participants.
Verified March 2013 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Germaine Cuff, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01809730
First received: March 11, 2013
Last updated: March 12, 2013
Last verified: March 2013

March 11, 2013
March 12, 2013
May 2012
January 2020   (final data collection date for primary outcome measure)
  • Cardiac ischemia/necrosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Venous thromboembolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Pulmonary embolism [ Time Frame: 30 dyas ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Cerebral vascular event [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Transient ischemic attack [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Surgical site infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Delayed wound healing [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinically relevant bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Transfusion within 48 hours post-op [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01809730 on ClinicalTrials.gov Archive Site
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Not Provided
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Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

Probability Sample

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.

  • Coronary Artery Disease
  • Cerebral Vascular Disease
  • Peripheral Artery Disease
  • Renal Insufficiency
  • Diabetes
  • COPD
  • Hypertension
  • Active Smoker
  • Cancer
  • CHF
  • Prior DVT/PE
Not Provided
Cardiovascular risk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
January 2020
January 2020   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Not Provided
United States
 
NCT01809730
S12-02513
No
Germaine Cuff, New York University School of Medicine
New York University School of Medicine
Not Provided
Not Provided
New York University School of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP