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)
Overview
- Phase
- Not Applicable
- Intervention
- Alteplase (Actilyse)
- Conditions
- Myocardial Infarction
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 59
- Primary Endpoint
- Percentage of equipment function / reliability
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility 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)
Arms & Interventions
Administration of thrombolytic treatment with PHARAOH
Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)
Intervention: Alteplase (Actilyse)
Standard therapy with thrombolytic treatment in Hospital
Intervention: Standard therapy
Outcomes
Primary Outcomes
Percentage of equipment function / reliability
Time Frame: Up to 12 month after drug administration
Time between pre-hospital evaluation and treatment
Time Frame: Up to 12 month after drug administration
Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics
Time Frame: Up to 12 month after drug administration
Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Time Frame: Up to 12 month after drug administration
Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Time Frame: 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
Time Frame: Up to 12 month after drug administration
Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
Time Frame: Up to 12 month after drug administration
Number of patients with adverse events
Time Frame: Up to 12 month after drug administration
Patient status at 30 days post myocardial infarction
Time Frame: Up to 30 days after drug administration