Myocardial Infarction
Conditions
Brief summary
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
Interventions
DRUGAlteplase (Actilyse)
DRUGStandard therapy
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed