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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02194153
First received: July 17, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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
Metalyse weight-adjusted
Drug: Metalyse weight-adjusted

  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov 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:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 11, 2014