A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®)

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Alteplase (Actilyse)
* Drug: Standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Administration of thrombolytic treatment with PHARAOH<br>Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH) | Drug: Alteplase (Actilyse)<br> <br> |
| Standard therapy with thrombolytic treatment in Hospital<br> | Drug: Standard therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of equipment function / reliability |  | Up to 12 month after drug administration | 
| Time between pre-hospital evaluation and treatment |  | Up to 12 month after drug administration | 
| Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics |  | Up to 12 month after drug administration | 
| Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation |  | Up to 12 month after drug administration | 
| Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation |  | 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 |  | Up to 12 month after drug administration | 
| Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG) |  | Up to 12 month after drug administration | 
| Number of patients with adverse events |  | Up to 12 month after drug administration | 
| Patient status at 30 days post myocardial infarction |  | Up to 30 days after drug administration |