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Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
PCI
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Fibrinolysis, Health effects /Quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulleval University Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Size of infarction.
Complications

Full Information

First Posted
September 9, 2005
Last Updated
April 16, 2009
Sponsor
Ullevaal University Hospital
Collaborators
Helse Innlandet
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1. Study Identification

Unique Protocol Identification Number
NCT00161005
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital
Collaborators
Helse Innlandet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Fibrinolysis, Health effects /Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
Immediate transport to invasive center after thrombolysis
Primary Outcome Measure Information:
Title
Death , myocardial infarction ,stroke or ischemia during 12 months.
Time Frame
12 months
Title
Costs during 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Size of infarction.
Time Frame
3 months
Title
Complications
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigrun Halvorsen@uus.no, dr.med
Organizational Affiliation
UUS, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24828790
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.
Results Reference
derived
PubMed Identifier
22607887
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.
Results Reference
derived
PubMed Identifier
21450598
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.
Results Reference
derived
PubMed Identifier
20598975
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.
Results Reference
derived
PubMed Identifier
19747792
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.
Results Reference
derived
PubMed Identifier
17365975
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.
Results Reference
derived

Learn more about this trial

Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction

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