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®)

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tissue Plasminogen Activator

Criteria

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