Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
21 Years
N/A
Both
Coronary Artery Disease, Cerebral Vascular Disease, Peripheral Artery Disease, Renal Insufficiency, Diabetes, COPD, Hypertension, Active Smoker, Cancer, CHF, Prior DVT/PE
Trial Information
Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Cardiac ischemia/necrosis
Outcome Time Frame:
30 days
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
S12-02513
NCT ID:
NCT01809730
Start Date:
May 2012
Completion Date:
January 2020
Related Keywords:
- Coronary Artery Disease
- Cerebral Vascular Disease
- Peripheral Artery Disease
- Renal Insufficiency
- Diabetes
- COPD
- Hypertension
- Active Smoker
- Cancer
- CHF
- Prior DVT/PE
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Hypertension
- Renal Insufficiency
- Vascular Diseases
- Peripheral Arterial Disease
Name | Location |
|---|---|
| NYU Hospital for Joint Diseases | New York, New York 10003 |
