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Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161005
Recruitment Status : Unknown
Verified April 2009 by Ullevaal University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : April 17, 2009
Sponsor:
Collaborator:
Helse Innlandet
Information provided by:
Ullevaal University Hospital

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date April 17, 2009
Study Start Date  ICMJE February 2005
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: September 9, 2005)
  • Death , myocardial infarction ,stroke or ischemia during 12 months.
  • Costs during 12 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
  • Size of infarction. [ Time Frame: 3 months ]
  • Complications [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE Procedure: PCI
Immediate transport to invasive center after thrombolysis
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 9, 2005)
266
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161005
Other Study ID Numbers  ICMJE 2935-0304 (UUS)
2004-162 (Helse Oest)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party dr.Sigrun Halvorsen, Hjertemed avd., UUH
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE Helse Innlandet
Investigators  ICMJE
Principal Investigator: Sigrun Halvorsen@uus.no, dr.med UUS, Oslo, Norway
PRS Account Ullevaal University Hospital
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP