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®) (PHARAOH)

September 9, 2014 updated by: Boehringer Ingelheim

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of equipment function / reliability
Time Frame: Up to 12 month after drug administration
Up to 12 month after drug administration
Time between pre-hospital evaluation and treatment
Time Frame: Up to 12 month after drug administration
Up to 12 month after drug administration
Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics
Time Frame: Up to 12 month after drug administration
Up to 12 month after drug administration
Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Time Frame: Up to 12 month after drug administration
Up to 12 month after drug administration
Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Time Frame: Up to 12 month after drug administration
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
Time Frame: Up to 12 month after drug administration
Up to 12 month after drug administration
Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
Time Frame: Up to 12 month after drug administration
Up to 12 month after drug administration
Number of patients with adverse events
Time Frame: Up to 12 month after drug administration
Up to 12 month after drug administration
Patient status at 30 days post myocardial infarction
Time Frame: Up to 30 days after drug administration
Up to 30 days after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 1998

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 135.301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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