Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction

• ClinicalTrials.gov Identifier: NCT00161005
• Recruitment Status: Unknown
• First Posted: September 12, 2005
• Last Update Posted: April 17, 2009
• Sponsor: Ullevaal University Hospital
• Collaborator: Helse Innlandet
• Information provided by: Ullevaal University Hospital

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 12, 2005
• Last Update Posted Date: April 17, 2009
• Study Start Date: February 2005
• Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 15, 2008)

• Death , myocardial infarction ,stroke or ischemia during 12 months. [ Time Frame: 12 months ]
• Costs during 12 months. [ Time Frame: 12 months ]

Original Primary Outcome Measures (submitted: September 9, 2005)

• Death , myocardial infarction ,stroke or ischemia during 12 months.
• Costs during 12 months.

Current Secondary Outcome Measures (submitted: April 15, 2008)

• Size of infarction. [ Time Frame: 3 months ]
• Complications [ Time Frame: 1 month ]

Original Secondary Outcome Measures (submitted: September 9, 2005)

• Size of infarction.
• Complications

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction

Intervention

Procedure: PCI

Immediate transport to invasive center after thrombolysis

• Study Arms: Not Provided

Publications *

• Bøhmer 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.
• Halvorsen S, Seljeflot I, Weiss T, Bøhmer 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.
• Bøhmer 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.
• Mistry N, Bøhmer E, Hoffmann P, Müller C, Bjørnerheim 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.
• Bøhmer 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.
• Bøhmer 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 9, 2005): 266
• Original Enrollment: Same as current
• Estimated Study Completion Date: December 2009
• Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT00161005
• Other Study ID Numbers: 2935-0304 (UUS); 2004-162 (Helse Oest)
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: dr.Sigrun Halvorsen, Hjertemed avd., UUH
• Study Sponsor: Ullevaal University Hospital
• Collaborators: Helse Innlandet

Investigators

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

• PRS Account: Ullevaal University Hospital
• Verification Date: April 2009