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®) (PHARAOH)

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)

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

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Alteplase (Actilyse); Drug: Standard therapy

• Study Type: Observational
• Enrollment (Actual): 59

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myocardial infarction treated by paramedics under the direction of hospital physicians

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Administration of thrombolytic treatment with PHARAOH; Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)	Drug: Alteplase (Actilyse)
Standard therapy with thrombolytic treatment in Hospital	Drug: Standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 1998
• Primary Completion (Actual): December 1, 1998

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Estimate): September 10, 2014
• Last Update Submitted That Met QC Criteria: September 9, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: 135.301