Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction
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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
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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 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 |

- Procedure: PCI
Immediate transport to invasive center after thrombolysis
- Death , myocardial infarction ,stroke or ischemia during 12 months. [ Time Frame: 12 months ]
- Costs during 12 months. [ Time Frame: 12 months ]
- Size of infarction. [ Time Frame: 3 months ]
- Complications [ Time Frame: 1 month ]

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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 |
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

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
Norway | |
Ulleval University Hospital | |
Oslo, Norway, 0407 |
Principal Investigator: | Sigrun Halvorsen@uus.no, dr.med | UUS, Oslo, Norway |
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 |
Acute myocardial infarction Fibrinolysis Health effects /Quality of life |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |