Prognosis Significance of Troponin T Elevation as Detected by Highly Sensitive Assay in Patient Undergoing Hip Fracture Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of patients with elevated HS Tn T levels post operatively.
研究概览
简要总结
Background: Patients undergoing hip fracture surgery are elderly and usually have co-morbidities; hence they are at risk for perioperative MI. Troponin is the gold standard for diagnosis of myocardial damage and currently the cornerstone of MI diagnosis. Perioperative troponin elevation is a poor prognosis factor. The significance of minor troponin elevation, detected by highly sensitivity troponin T assay, is unknown.
Objectives: To determine the frequency of perioperative troponin T elevation using highly sensitivity troponin T assay, and to determine the clinical significance of this elevation.
Methods: Serum Troponin T levels of patients undergoing hip fracture surgery will be tested prior to surgery 48 hrs and 72 hrs after surgery, using highly sensitivity troponin T assay.
Patients will be followed for 1 year. Primary outcomes- The number of patients with elevated troponin levels perioperatively and cardiac mortality at 3 months, 6 months and 1 year.
详细描述
Background and Rational
Hip fractures are an important cause of morbidity and mortality in the elderly. Surgery (i.e. total hip fracture surgery or replacement) is associated with better outcome; however these elderly patients have other comorbidities which put them at risk for non surgical perioperative complications .
Peri-operative myocardial infarction (MI) is associated with increased mortality and morbidity . Peri-operative MI currently diagnosed by presence of either symptoms or ischemic ECG changes, together with an elevated troponin level as measured by conventional assay.
The new highly sensitive troponin T (HS Tn T) assay, permitting measurement of concentrations that are lower by a factor of 10 than those measurable with conventional assays .
Research Objectives
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 65 years, admitted with traumatic femoral neck fracture undergoing surgery
排除标准
- •Patients who will not undergo surgery
- •Patients whom clinical singes and baseline troponin (prior to surgery) will suggest an acute myocardial infarction
- •Patient younger than 65 years
结局指标
主要结局
The number of patients with elevated HS Tn T levels post operatively.
时间窗: One year
Cardiac mortality
时间窗: one year
次要结局
- Total mortality(One year)
- Any hospitlization(One year)
研究者
David Rott
Consultant
Hadassah Medical Organization