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

July 17, 2014 updated by: Boehringer Ingelheim

Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

351

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

prehospital or emergency room patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete ST-segment resolution
Time Frame: up to 30 days
up to 30 days
Pain relief
Time Frame: 90 min, 120 min, up to 30 days after treatment initiation
yes/no question
90 min, 120 min, up to 30 days after treatment initiation
Change in creatine kinase (CK)
Time Frame: up to 24 hours
up to 24 hours
Change in creatine kinase-MB (CK-MB)
Time Frame: up to 24 hours
up to 24 hours
Change in troponin
Time Frame: up to 24 hours
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1123.16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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