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Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Ullevaal University Hospital.   Recruitment status was  Active, not recruiting

First Received on September 9, 2005.   Last Updated on April 16, 2009   History of Changes
Sponsor: Ullevaal University Hospital
Collaborator: Helse Innlandet
Information provided by: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00161005
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
 Procedure: PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Death , myocardial infarction ,stroke or ischemia during 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Costs during 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Size of infarction. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 266
Study Start Date: February 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: PCI
    Immediate transport to invasive center after thrombolysis
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161005

Locations
Norway
Ulleval University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Helse Innlandet
Investigators
Principal Investigator: Sigrun Halvorsen@uus.no, dr.med UUS, Oslo, Norway
  More Information

No publications provided by Ullevaal University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. 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.
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. Epub 2009 Sep 10.
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.

Responsible Party: dr.Sigrun Halvorsen, Hjertemed avd., UUH
ClinicalTrials.gov Identifier: NCT00161005     History of Changes
Other Study ID Numbers: 2935-0304 (UUS), 2004-162 (Helse Oest)
Study First Received: September 9, 2005
Last Updated: April 16, 2009
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Ullevaal University Hospital:
Acute myocardial infarction
Fibrinolysis
Health effects /Quality of life

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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