Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Transient ischemic attack
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• ≥ 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)
- •Chronic Obstructive Pulmonary Disease (COPD)
- •Hypertension
- •Active smoker or stopped less than 30 days prior to consent
- •Congestive heart failure
- •Prior blood clot
排除标准
- •• Severe co-morbid condition with life expectancy < 6 months
- •Inability to give informed consent or adhere to follow-up as per protocol
结局指标
主要结局
Transient ischemic attack
时间窗: 30 days
Surgical site infection
时间窗: 30 days
Cardiac ischemia/necrosis
时间窗: 30 days
Pulmonary embolism
时间窗: 30 dyas
Cerebral vascular event
时间窗: 30 days
Clinically relevant bleeding
时间窗: 30 days
Transfusion within 48 hours post-op
时间窗: 30 days
Venous thromboembolism
时间窗: 30 days
Myocardial infarction
时间窗: 30 Days
Delayed wound healing
时间窗: 30 days
Death
时间窗: 30 days
次要结局
未报告次要终点