NCT02194153

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

July 17, 2014

Last Update Submit

July 17, 2014

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (5)

  • Complete ST-segment resolution

    up to 30 days

  • Pain relief

    yes/no question

    90 min, 120 min, up to 30 days after treatment initiation

  • Change in creatine kinase (CK)

    up to 24 hours

  • Change in creatine kinase-MB (CK-MB)

    up to 24 hours

  • Change in troponin

    up to 24 hours

Study Arms (1)

Metalyse

Metalyse weight-adjusted

Drug: Metalyse weight-adjusted

Interventions

Metalyse weight-adjustedDRUG
Metalyse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

prehospital or emergency room patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 18, 2014

Study Start

May 1, 2001

Primary Completion

March 1, 2003

Last Updated

July 18, 2014

Record last verified: 2014-07