Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
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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 |
- 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 |
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.
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| 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 | |
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:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Hypertension Renal Insufficiency Vascular Diseases 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 May 19, 2013