Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+30
+ Arterial Occlusive Diseases
+ Arteriosclerosis
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
NYU Hospital for Joint Diseases
New York, United StatesOpen NYU Hospital for Joint Diseases in Google Maps