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Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

This study has been withdrawn prior to enrollment.
(no participants enrolled)
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01809730
First received: March 11, 2013
Last updated: November 16, 2015
Last verified: November 2015
  Purpose
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
Coronary Artery Disease Cerebral Vascular Disease Peripheral Artery Disease Renal Insufficiency Diabetes COPD Hypertension Active Smoker Cancer CHF Prior DVT/PE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Further study details as provided by New York University School of Medicine:

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

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

Enrollment: 0
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiovascular risk
patients with CV disease

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.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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.
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809730

Locations
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
Sponsors and Collaborators
New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01809730     History of Changes
Other Study ID Numbers: S12-02513
Study First Received: March 11, 2013
Last Updated: November 16, 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Renal Insufficiency
Peripheral Arterial Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Kidney Diseases
Urologic Diseases
Atherosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2017