A Multicentre, Feasibility Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®). Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 主要终点
- Percentage of equipment function / reliability
研究概览
简要总结
The general aim of this study was to assess the feasibility of treating acute myocardial infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition by paramedics
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic cardiac pain of >= 20 minutes and <= 6 hours
- •Age 18 - 80 years
- •Ability to give informed consent (witnessed verbal or written)
- •Ability to follow protocol and comply with follow -up requirements
排除标准
- •Current participation in another clinical trial
- •Patient will be ineligible for pre hospital administration of actilyse if any of the following apply:
- •Acute myocardial infarction (AMI) treated with a thrombolytic agent within the preceding 4 days
- •BP (blood pressure) > 180/100 mmHg (on one measurement)
- •Significant bleeding disorder within the past 6 months
- •Major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current AMI) within 3 months
- •History of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery)
- •Oral anticoagulation
- •Recent (within 10 days) non - compressible vascular puncture
- •Pregnancy (positive urine pregnancy test) or lactation, parturition within the previous 30 days, or female of childbearing potential not using adequate birth control (oral contraception)
- •Severe liver disease, including hepatic failure, cirrhosis portal hypertension (oesophageal varices) and active hepatitis
- •Diabetes with definite history of retinopathy
- •Other serious illness (e.g. malignancy, active infection)
- •Bacterial endocarditis / pericarditis
- •Acute pancreatitis
- •Documented ulcerative gastrointestinal disease during last 3 month, arterial aneurysms, arterial / venous malformations
- •Any other condition that the investigator feels would pose a significant hazard to the subject if the investigational therapy was to be initiated
- •Patients who are not excluded from thrombolytic therapy by the criteria above will, in addition, need to satisfy the following 'inclusion' criteria prior to the pre - hospital thrombolysis:
- •12 lead ECG criteria: ST segment elevation >= 0.1 mV in two contiguous electrocardiogram (ECG) standard leads indicative of AMI, or ST elevation >= 0.2 mV in two contiguous chest leads and all left bundle branch block (LBBB) with clinical indication of AMI
研究组 & 干预措施
Administration of thrombolytic treatment with PHARAOH
Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)
干预措施: Alteplase (Actilyse) (Drug)
Standard therapy with thrombolytic treatment in Hospital
干预措施: Standard therapy (Drug)
结局指标
主要结局
Percentage of equipment function / reliability
时间窗: Up to 12 month after drug administration
Time between pre-hospital evaluation and treatment
时间窗: Up to 12 month after drug administration
Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics
时间窗: Up to 12 month after drug administration
Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
时间窗: Up to 12 month after drug administration
Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
时间窗: Up to 12 month after drug administration
Percentage of patients receiving pre- hospital thrombolysis in the absence of a subsequently confirmed diagnosis of acute myocardial infarction
时间窗: Up to 12 month after drug administration
Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
时间窗: Up to 12 month after drug administration
Number of patients with adverse events
时间窗: Up to 12 month after drug administration
Patient status at 30 days post myocardial infarction
时间窗: Up to 30 days after drug administration
次要结局
未报告次要终点