Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction With High Sensitivity Troponin T in Different Scenarios (IN-HOspital Program to SystematizE Chest Pain Protocol-IN HOPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,497
- 试验地点
- 1
- 主要终点
- Accuracy of early rule out for myocardial infarction diagnosis
研究概览
简要总结
Multicenter Nationwide Study for Analysis of the Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction with High Sensitivity Troponin T
详细描述
Chest pain is the main clinical complaint in emergency room visits and represents the most common symptom of Acute Myocardial Infarction, which is the main cause of death in Brazil and worldwide. Although most patients with chest pain do not have a final diagnosis of AMI, they remain under observation until the diagnosis of AMI is excluded. The most current strategy recommended for rapid AMI exclusion uses high-sensitivity cardiac troponin T at time zero and one hour later. However, some points that have not yet been properly evaluated in previous studies can be evaluated in the current study:
- Evaluation of the early exclusion protocol (0 -1 hour) in a Brazilian population
- Evaluation of the early exclusion protocol (0 -1 hour) in isolation and associated with traditional risk scores (TIMI, GRACE, HEART and EDACS)
- Systematic evaluation of the early exclusion protocol (0 -1 hour) in patients without chest pain but with a pre-defined condition of suspected AMI
- Evaluation of the prognostic value of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years of age
- •The patient agrees and signs an informed consent form
- •One of the following 2 criteria:
- •Acute chest pain (last episode of pain beginning <6 hours after inclusion) or
- •Syncope, dyspnea or epigastric pain without an obvious cause at the initial assessment (last episode of one of these symptoms beginning <6 hours after inclusion) associated with at least one of the following factors: Age ≥ 65 years, history of arterial disease, history of diabetes mellitus.
排除标准
- •Cardiac arrest or hypoxemia or hemodynamic instability or cardioversion during the first hour of assessment
- •Thrombolytic therapy, primary angioplasty or other medical condition that requires hospitalization identified within one hour after the evaluation
- •Dialysis patients
- •Patients with trauma
- •Myocardial revascularization or acute myocardial infarction in the last month
- •Pregnant and breastfeeding women
- •Patient unable to be followed for 30 days
结局指标
主要结局
Accuracy of early rule out for myocardial infarction diagnosis
时间窗: 30 days
Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours
次要结局
- Accuracy of early rule out for myocardial infarction according to chest pain score (HEART)(30 days)
- Accuracy of early rule out for myocardial infarction according to type of symptoms(30 days)
- Accuracy of early rule out for myocardial infarction according to chest pain score (EDACS)(30 days)
- Accuracy of early rule out for myocardial infarction according to chest pain score (GRACE)(30 days)
- Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.(30 days)
- Accuracy of early rule out for myocardial infarction according to chest pain score (TIMI)(30 days)
研究者
Pedro Gabriel Melo de Barros e Silva
Principal Investigator
Hospital Samaritano Paulista