Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.


Estimated Enrollment: 3000
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

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
Genders Eligible for Study:   Both
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 Recruiting
New York, New York, United States, 10003
Contact: Germaine Cuff, BSN, MPH, PHD    212-598-6074    germaine.cuff@nyumc.org   
Principal Investigator: Germaine Cuff, PhD         
Sponsors and Collaborators
New York University School of Medicine
  More Information

No publications provided

Responsible Party: Germaine Cuff, Program Director, Research, 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: March 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014