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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®)

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction

Intervention: Alteplase (Actilyse) (Drug); Standard therapy (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Boehringer Ingelheim

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

Clinical Details

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)

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome:

Percentage of equipment function / reliability

Time between pre-hospital evaluation and treatment

Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics

Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation

Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation

Percentage of patients receiving pre- hospital thrombolysis in the absence of a subsequently confirmed diagnosis of acute myocardial infarction

Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)

Number of patients with adverse events

Patient status at 30 days post myocardial infarction

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: February 1998
Last updated: September 9, 2014

Page last updated: August 20, 2015

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