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Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse

Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02194153
Enrollment
351
Registered
2014-07-18
Start date
2001-05-31
Completion date
Unknown
Last updated
2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Brief 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.

Interventions

DRUGMetalyse weight-adjusted

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Complete ST-segment resolutionup to 30 days
Pain relief90 min, 120 min, up to 30 days after treatment initiationyes/no question
Change in creatine kinase (CK)up to 24 hours
Change in creatine kinase-MB (CK-MB)up to 24 hours
Change in troponinup to 24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026