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
Percentage of equipment function / reliabilityTime between pre-hospital evaluation and treatment
Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics
Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Percentage of patients receiving pre- hospital thrombolysis in the absence of a subsequently confirmed diagnosis of acute myocardial infarction
Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
Number of patients with adverse events
Patient status at 30 days post myocardial infarction
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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