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

Completed

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metalyse weight-adjusted

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2003
First posted: Jul 18, 2014
Registry last updated: Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed