Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of thrombolytic treatment with PHARAOH | Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH) |
| |
| Standard therapy with thrombolytic treatment in Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase (Actilyse) | Drug |
| ||
| Standard therapy |
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Current participation in another clinical trial
Patient will be ineligible for pre hospital administration of actilyse if any of the following apply:
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:
Not provided
Not provided
Patients with acute myocardial infarction treated by paramedics under the direction of hospital physicians
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided