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®)

NCT02235389 | Terminated

• 1 other identifier: 135.301
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Administration of thrombolytic treatment with PHARAOH

Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)

Drug: Alteplase (Actilyse)

Standard therapy with thrombolytic treatment in Hospital

Drug: Standard therapy

Interventions

Alteplase (Actilyse) DRUG

Administration of thrombolytic treatment with PHARAOH

Standard therapy DRUG

Standard therapy with thrombolytic treatment in Hospital

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myocardial infarction treated by paramedics under the direction of hospital physicians

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Tissue Plasminogen Activator; Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 10, 2014
• Study Start: February 1, 1998
• Primary Completion: December 1, 1998
• Last Updated: September 10, 2014

Record last verified: 2014-09