Clinical trial NCT01809730: Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
Official title: Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Cerebral Vascular Disease
Peripheral Artery Disease
Renal Insufficiency
Diabetes
COPD
Hypertension
Active Smoker
Cancer
CHF
Prior DVT/PE
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Cardiac ischemia/necrosis
timeFrame: 30 days
measure: Venous thromboembolism
timeFrame: 30 days
measure: Pulmonary embolism
timeFrame: 30 dyas
measure: Myocardial infarction
timeFrame: 30 Days
measure: Cerebral vascular event
timeFrame: 30 days
measure: Death
timeFrame: 30 days
measure: Transient ischemic attack
timeFrame: 30 days
measure: Surgical site infection
timeFrame: 30 days
measure: Delayed wound healing
timeFrame: 30 days
measure: Clinically relevant bleeding
timeFrame: 30 days
measure: Transfusion within 48 hours post-op
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
Study officials:
References: