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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: PCI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.
Study Start Date : February 2005
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Intervention Details:
  • Procedure: PCI
    Immediate transport to invasive center after thrombolysis

Outcome Measures
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Primary Outcome Measures :
  1. Death , myocardial infarction ,stroke or ischemia during 12 months. [ Time Frame: 12 months ]
  2. Costs during 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Size of infarction. [ Time Frame: 3 months ]
  2. Complications [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161005


Locations
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Norway
Ulleval University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Helse Innlandet
Investigators
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Principal Investigator: Sigrun Halvorsen@uus.no, dr.med UUS, Oslo, Norway
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: dr.Sigrun Halvorsen, Hjertemed avd., UUH
ClinicalTrials.gov Identifier: NCT00161005    
Other Study ID Numbers: 2935-0304 (UUS)
2004-162 (Helse Oest)
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009
Keywords provided by Ullevaal University Hospital:
Acute myocardial infarction
Fibrinolysis
Health effects /Quality of life
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases