NCT00161005

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

4.3 years

First QC Date

September 9, 2005

Last Update Submit

April 16, 2009

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionFibrinolysisHealth effects /Quality of life

Outcome Measures

Primary Outcomes (2)

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

    12 months

  • Costs during 12 months.

    12 months

Secondary Outcomes (2)

  • Size of infarction.

    3 months

  • Complications

    1 month

Interventions

PCIPROCEDURE

Immediate transport to invasive center after thrombolysis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital

Oslo, 0407, Norway

Location

Related Publications (6)

  • 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.

    PMID: 24828790DERIVED

  • 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.

    PMID: 22607887DERIVED

  • 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.

    PMID: 21450598DERIVED

  • 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.

    PMID: 20598975DERIVED

  • 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.

    PMID: 19747792DERIVED

  • 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.

    PMID: 17365975DERIVED

Study Officials

  • Sigrun Halvorsen@uus.no, dr.med

    UUS, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

February 1, 2005

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

NO(1)