Clinical trial NCT00161005: Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction
Official title: Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Fibrinolysis
Health effects /Quality of life
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Innlandet
First posted: 2005-09-12
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Death , myocardial infarction ,stroke or ischemia during 12 months.
timeFrame: 12 months
measure: Costs during 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Size of infarction.
timeFrame: 3 months
measure: Complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: UUS, Oslo, Norway
name: Sigrun Halvorsen@uus.no, dr.med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bohmer E, Kristiansen IS, Arnesen H, Halvorsen S. Health-related quality of life after myocardial infarction, does choice of method make a difference? Scand Cardiovasc J. 2014 Aug;48(4):216-22. doi: 10.3109/14017431.2014.923581. Epub 2014 Jun 26.
citation: Halvorsen S, Seljeflot I, Weiss T, Bohmer E, Arnesen H. Inflammatory and thrombotic markers in patients with ST-elevation myocardial infarction treated with thrombolysis and early PCI: a NORDISTEMI substudy. Thromb Res. 2012 Sep;130(3):495-500. doi: 10.1016/j.thromres.2012.04.016. Epub 2012 May 17.
citation: Bohmer E, Kristiansen IS, Arnesen H, Halvorsen S. Health and cost consequences of early versus late invasive strategy after thrombolysis for acute myocardial infarction. Eur J Cardiovasc Prev Rehabil. 2011 Oct;18(5):717-23. doi: 10.1177/1741826711398425. Epub 2011 Feb 18.
citation: Mistry N, Bohmer E, Hoffmann P, Muller C, Bjornerheim R, Kjeldsen SE, Halvorsen S. Left ventricular function in acute myocardial infarction treated with thrombolysis followed by early versus late invasive strategy. Am Heart J. 2010 Jul;160(1):73-9. doi: 10.1016/j.ahj.2010.04.011.
citation: Bohmer E, Hoffmann P, Abdelnoor M, Arnesen H, Halvorsen S. Efficacy and safety of immediate angioplasty versus ischemia-guided management after thrombolysis in acute myocardial infarction in areas with very long transfer distances results of the NORDISTEMI (NORwegian study on DIstrict treatment of ST-elevation myocardial infarction). J Am Coll Cardiol. 2010 Jan 12;55(2):102-10. doi: 10.1016/j.jacc.2009.08.007. Epub 2009 Sep 10.
citation: Bohmer E, Arnesen H, Abdelnoor M, Mangschau A, Hoffmann P, Halvorsen S. The NORwegian study on DIstrict treatment of ST-elevation myocardial infarction (NORDISTEMI). Scand Cardiovasc J. 2007 Jan;41(1):32-8. doi: 10.1080/14017430601153472.