Myocardial InfarctionPHARAOHNCT02235389
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®)
An observational study of Myocardial Infarction, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Alteplase (Actilyse) and Standard therapy
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to Dec 1998
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute myocardial infarction treated by paramedics under the direction of hospital physicians
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
About this study
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)
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
- Being tested
- Alteplase (Actilyse), Standard therapy
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteplase (Actilyse)Drug
Standard therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Administration of thrombolytic treatment with PHARAOH | Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH) Receives: Drug: Alteplase (Actilyse) | |
| Standard therapy with thrombolytic treatment in Hospital | Not described Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of equipment function / reliability
Measured: Up to 12 month after drug administration
Time between pre-hospital evaluation and treatment
Measured: Up to 12 month after drug administration
Percentage of acute myocardial infarction (AMI) patients, whose symptoms were recognized by paramedics
Measured: Up to 12 month after drug administration
Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Measured: Up to 12 month after drug administration
Percentage of patients incorrectly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Measured: 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
Measured: Up to 12 month after drug administration
Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
Measured: Up to 12 month after drug administration
Number of patients with adverse events
Measured: Up to 12 month after drug administration
Patient status at 30 days post myocardial infarction
Measured: Up to 30 days after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startFeb 1998
- Primary completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235389
- Sponsor's protocol ID
- 135.301
- Acronym
- PHARAOH
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02235389
- Acronym / sponsor ID
- PHARAOH / 135.301
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of thrombolytic treatment with PHARAOH | – | Drug: Alteplase (Actilyse)Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH) |
| Standard therapy with thrombolytic treatment in Hospital | – | Drug: Standard therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute myocardial infarction treated by paramedics under the direction of hospital physicians
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alteplase (Actilyse) | Drug | Administration of thrombolytic treatment with PHARAOH |
| Standard therapy | Drug | Standard therapy with thrombolytic treatment in Hospital |
Primary outcome
Percentage of equipment function / reliability
Time frame: Up to 12 month after drug administration
Time between pre-hospital evaluation and treatment
Time frame: 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
Percentage of patients correctly diagnosed as suffering acute myocardial infarction by remote ECG interpretation
Time frame: 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
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
Percentage of patients giving consent to pre- hospital evaluation using remote electrocardiogram (ECG)
Time frame: Up to 12 month after drug administration
Number of patients with adverse events
Time frame: Up to 12 month after drug administration
Patient status at 30 days post myocardial infarction
Time frame: Up to 30 days after drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of equipment function / reliability (time frame: Up to 12 month after drug administration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.