Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse
Overview
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.
Full Title of Study: “Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 2003
Interventions
- Drug: Metalyse weight-adjusted
Arms, Groups and Cohorts
- Metalyse
- Metalyse weight-adjusted
Clinical Trial Outcome Measures
Primary Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Boehringer Ingelheim
- Provider of Information About this Clinical Study
- Sponsor
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