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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