Status:
TERMINATED
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®)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 1998
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT02235389
Start Date
February 1 1998
Last Update
September 10 2014
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