Overview

This trial is active, not recruiting.

Condition acute myocardial infarction
Treatment pci
Sponsor Ullevaal University Hospital
Collaborator Helse Innlandet
Start date February 2005
End date June 2009
Trial size 266 participants
Trial identifier NCT00161005, 2004-162 (Helse Oest), 2935-0304 (UUS)

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Death , myocardial infarction ,stroke or ischemia during 12 months.
time frame: 12 months
Costs during 12 months.
time frame: 12 months

Secondary Outcomes

Measure
Size of infarction.
time frame: 3 months
Complications
time frame: 1 month

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.
Principal investigator Sigrun Halvorsen@uus.no, dr.med
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Ullevaal University Hospital.