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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 17, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
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.

Condition Intervention
Myocardial Infarction
Drug: Metalyse weight-adjusted

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Complete ST-segment resolution [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
  • Pain relief [ Time Frame: 90 min, 120 min, up to 30 days after treatment initiation ] [ Designated as safety issue: No ]
    yes/no question

  • Change in creatine kinase (CK) [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
  • Change in creatine kinase-MB (CK-MB) [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
  • Change in troponin [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: May 2001
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metalyse weight-adjusted
Drug: Metalyse weight-adjusted


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
prehospital or emergency room patients

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim Identifier: NCT02194153     History of Changes
Other Study ID Numbers: 1123.16 
Study First Received: July 17, 2014
Last Updated: July 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2016