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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02194153
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment
Myocardial Infarction Drug: Metalyse weight-adjusted

Study Type : Observational
Actual Enrollment : 351 participants
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 ®
Study Start Date : May 2001
Actual Primary Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Group/Cohort Intervention/treatment
Metalyse weight-adjusted
Drug: Metalyse weight-adjusted

Primary Outcome Measures :
  1. Complete ST-segment resolution [ Time Frame: up to 30 days ]
  2. Pain relief [ Time Frame: 90 min, 120 min, up to 30 days after treatment initiation ]
    yes/no question

  3. Change in creatine kinase (CK) [ Time Frame: up to 24 hours ]
  4. Change in creatine kinase-MB (CK-MB) [ Time Frame: up to 24 hours ]
  5. Change in troponin [ Time Frame: up to 24 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Boehringer Ingelheim Identifier: NCT02194153     History of Changes
Other Study ID Numbers: 1123.16
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action