Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction

April 16, 2009 updated by: Ullevaal University Hospital

Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.

In the district areas of Norway patients with acute myocardial infarction with ST-elevation, are treated with thrombolysis. An increasing part of them receives thrombolysis before arrival to the local hospital.Usually these patients have been sent to an invasive center if thrombolysis fails or the patient gets ischemic symptoms during the stay.

This study will compare this strategy against immediate transportation to an invasive center after the patient has received thrombolysis.

Study Overview

Status

Unknown

Conditions

Acute Myocardial Infarction

Intervention / Treatment

Procedure: PCI

Study Type

Interventional

Enrollment (Anticipated)

266

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0407
    - Ullevål University Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Duration of painless than 6 hours.
ST-segment elevation of at least 0.1 mV in two or more extremity leads or at least 0.2 mV in two or more precordial leads.
The patient is getting thrombolysis.
Time to reach an invasive center is more than 1 hour.
Age 18-75 years.

Exclusion Criteria:

Known serious renal failure (creatinin > 250 mmol/l)
Pregnancy
Cardiogenic chock
Life threatening arrythmias
Other serious diseases with life expectancy less than 1 year.
Inability to perform an informed consent

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

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death , myocardial infarction ,stroke or ischemia during 12 months. Time Frame: 12 months	12 months
Costs during 12 months. Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Size of infarction. Time Frame: 3 months	3 months
Complications Time Frame: 1 month	1 month

Collaborators and Investigators

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

Sponsor

Ullevaal University Hospital

Collaborators

Helse Innlandet

Investigators

Principal Investigator: Sigrun Halvorsen@uus.no, dr.med, UUS, Oslo, Norway

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.

General Publications

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

February 1, 2005

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria