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®)

Terminated

• Conditions: Myocardial Infarction
• Interventions: Drug: Alteplase (Actilyse); Drug: Standard therapy

• Registration Number: NCT02235389
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-02
• Primary Completion: 1998-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Study First Posted: 2014-09-10
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Administration of thrombolytic treatment with PHARAOH	Alteplase (Actilyse)	Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)
Standard therapy with thrombolytic treatment in Hospital	Standard therapy	-

Primary Outcome Measures

Name	Time	Method
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