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®)

Myocardial Infarction Clinical Trial

— PHARAOH  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02235389
• Other study ID #: 135.301
• Status: Terminated
• Phase: N/A
• First received: September 9, 2014
• Last updated: September 9, 2014
• Start date: February 1998

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. primary completion date: December 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Alteplase (Actilyse)

• Standard therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of equipment function / reliability		Up to 12 month after drug administration	No
Primary	Time between pre-hospital evaluation and treatment		Up to 12 month after drug administration	No
Primary	Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics		Up to 12 month after drug administration	No
Primary	Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation		Up to 12 month after drug administration	No
Primary	Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation		Up to 12 month after drug administration	No
Primary	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	No
Primary	Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)		Up to 12 month after drug administration	No
Primary	Number of patients with adverse events		Up to 12 month after drug administration	No
Primary	Patient status at 30 days post myocardial infarction		Up to 30 days after drug administration	No

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