Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction - Full Text View

Sponsors and Collaborators:	Ullevaal University Hospital 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

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.

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:

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

Publications indexed to this study:

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:	Hjertemed avd., UUH ( dr.Sigrun Halvorsen )
Study ID Numbers:	2935-0304 (UUS), 2004-162 (Helse Oest)
Study First Received:	September 9, 2005
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00161005
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Ullevaal University Hospital:

Acute myocardial infarction
Fibrinolysis
Health effects /Quality of life

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Quality of Life
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009