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®)

NCT ID: NCT02235389

Last Updated: 2014-09-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1998-02-28

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

Conditions

Myocardial Infarction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Administration of thrombolytic treatment with PHARAOH

Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)

Alteplase (Actilyse)

Intervention Type: DRUG

Standard therapy with thrombolytic treatment in Hospital

Standard therapy

Intervention Type: DRUG

Interventions

Alteplase (Actilyse)

Intervention Type: DRUG

Standard therapy

Intervention Type: DRUG

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

135.301

Identifier Type: -

Identifier Source: org_study_id