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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194153
• Other study ID #: 1123.16
• Status: Completed
• Phase: N/A
• First received: July 17, 2014
• Last updated: July 17, 2014
• Start date: May 2001

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Metalyse weight-adjusted

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

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

External Links

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