Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,927
- 试验地点
- 1
- 主要终点
- Incidence of Acute Myocardial Infarction
研究概览
简要总结
Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI compared to contemporary cTnI assays.
The primary objective of the study is to determine the performance of a high sensitivity cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic accuracy of type 1 acute myocardial infarction (AMI).
The diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The sensitivity, specificity, positive predictive value and negative predictive value of the hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and potentially age derived 99th percentile upper reference limits (URL).
Investigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and percent changes over time) for their ability to contribute to the negative predictive value and hence potentially lead to an earlier rule out of AMI (improved specificity). Additionally, investigators will assess delta changes of the hs-cTnI assay for their potential contribution to the clinical differentiation of type 1 and type 2 (supply demand mismatch) MIs.
Lastly, investigators will compare the diagnosis of AMI based on the currently used contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the time to diagnosis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more cTnI values ordered for any clinical indication with specimen available for hs cTnI assay
- •18 years of age or older
- •EKG done on admission / presentation
- •Agree to research disclosure
排除标准
- •Admission through any venue other an emergency department
- •Repeat admission for the same patient, only primary admission will be assessed
- •Pregnancy
结局指标
主要结局
Incidence of Acute Myocardial Infarction
时间窗: Up to 6 months after last enrollment
Adjudicated diagnosis of acute myocardial infarction (AMI) to systematize the potentially earlier (0,3,6h) detection of AMI using the Abbott hs cTnI assay.
次要结局
- Repeat Cardiac hospitalization(Up to 6 months after last enrollment)
- 180 day mortality(Up to 6 months after last enrollment)
- In- hospital mortality(Up to 6 months after last enrollment)
- Time to repeat cardiac hospitalization(Up to 6 months after last enrollment)
- ACS Diagnosis(Up to 6 months after last enrollment)
- Repeat revascularization (bypass surgery versus percutaneous revascularization)(Up to 6 months after last enrollment)
- Emergency encounter for chest pain(Up to 6 months after last enrollment)
- New diagnosis of Congestive Heart Failure(Up to 6 months after last enrollment)
研究者
Fred Apple
PhD
Hennepin Healthcare Research Institute