Clinical trial NCT02235389: 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®)
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute myocardial infarction treated by paramedics under the direction of hospital physicians

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


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

Primary outcomes:
measure: Percentage of equipment function / reliability
timeFrame: Up to 12 month after drug administration
measure: Time between pre-hospital evaluation and treatment
timeFrame: Up to 12 month after drug administration
measure: Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics
timeFrame: Up to 12 month after drug administration
measure: Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
timeFrame: Up to 12 month after drug administration
measure: Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
timeFrame: Up to 12 month after drug administration
measure: Percentage of patients receiving pre- hospital thrombolysis in the absence of a subsequently confirmed diagnosis of acute myocardial infarction
timeFrame: Up to 12 month after drug administration
measure: Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
timeFrame: Up to 12 month after drug administration
measure: Number of patients with adverse events
timeFrame: Up to 12 month after drug administration
measure: Patient status at 30 days post myocardial infarction
timeFrame: Up to 30 days after drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: