Myocardial InfarctionNCT02194153
Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse
An observational study of Myocardial Infarction, run by Boehringer Ingelheim.
Trial summary
Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Metalyse weight-adjusted
- How many people
- 351 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Mar 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: prehospital or emergency room patients
Who may be able to join
- Male and female patient with suspected myocardial infarction, e.g. during transportation to the hospital by ambulance. No patient younger than 18 years.
- Possibility of obtaining relevant information concerning indication or contraindication of thrombolysis in each patient
- Typical chest pain with a duration of more than 30 minutes
- Definite infarction signs in a 12-lead-ECG with ST-elevation > 0.1 millivolt (mV) in > 2 leads or recent left bundle branch block with typical clinical signs
- Symptom onset <= 6 hours
Who cannot join
- Patients older than 75 years (exception: patients appear much younger)
- Low body weight
- No persons under 18
- contraindications according to summary of product characteristics (SPC) for Metalyse
About this study
Official title: Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®
Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical trials.
- Conditions
- Myocardial Infarction
- Being tested
- Metalyse weight-adjusted
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metalyse weight-adjustedDrug
| Study group | Role | What they receive |
|---|---|---|
| Metalyse | Metalyse weight-adjusted Receives: Drug: Metalyse weight-adjusted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ST-segment resolution
Measured: up to 30 days
Pain relief
yes/no question
Measured: 90 min, 120 min, up to 30 days after treatment initiation
Change in creatine kinase (CK)
Measured: up to 24 hours
Change in creatine kinase-MB (CK-MB)
Measured: up to 24 hours
Change in troponin
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startMay 2001
- Primary completionMar 2003
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351 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
- NCT02194153
- Sponsor's protocol ID
- 1123.16
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®
- ClinicalTrials.gov ID
- NCT02194153
- Acronym / sponsor ID
- 1123.16
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Mar 2003 (actual)
- First posted
- 18 Jul 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.
Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metalyse | – | Drug: Metalyse weight-adjustedMetalyse weight-adjusted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prehospital or emergency room patients
Key inclusion criteria (5 listed)
- Male and female patient with suspected myocardial infarction, e.g. during transportation to the hospital by ambulance. No patient younger than 18 years.
- Possibility of obtaining relevant information concerning indication or contraindication of thrombolysis in each patient
- Typical chest pain with a duration of more than 30 minutes
- Definite infarction signs in a 12-lead-ECG with ST-elevation > 0.1 millivolt (mV) in > 2 leads or recent left bundle branch block with typical clinical signs
- Symptom onset <= 6 hours
Key exclusion criteria (4 listed)
- Patients older than 75 years (exception: patients appear much younger)
- Low body weight
- No persons under 18
- contraindications according to summary of product characteristics (SPC) for Metalyse
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 |
|---|---|---|
| Metalyse weight-adjusted | Drug | Metalyse |
Primary outcome
Complete ST-segment resolution
Time frame: up to 30 days
Pain relief
Time frame: 90 min, 120 min, up to 30 days after treatment initiation
yes/no question
Change in creatine kinase (CK)
Time frame: up to 24 hours
Change in creatine kinase-MB (CK-MB)
Time frame: up to 24 hours
Change in troponin
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete ST-segment resolution (time frame: up to 30 days). The study lists 5 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 18 Jul 2014.