Norwegian Study on District Treatment of ST-Elevation Myo... | NCT00161005

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

NCT00161005

Sponsor

Ullevaal University Hospital

Status

Unknown status

Last Update Posted

Apr 17, 2009Estimated

Enrollment

266Estimated

Phase

Not Applicable

Conditions

Acute Myocardial Infarction

Interventions

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004-162 (Helse Oest)

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Jun 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2009

Last Update Posted Date

Apr 17, 2009Estimated

Name	Class
Helse Innlandet	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

266Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PCI	Procedure	Immediate transport to invasive center after thrombolysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death , myocardial infarction ,stroke or ischemia during 12 months.		12 months
Costs during 12 months.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Size of infarction.		3 months
Complications		1 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sigrun Halvorsen@uus.no, dr.med	UUS, Oslo, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ulleval University Hospital		Oslo		0407	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24828790	Derived	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.
22607887	Derived	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.

Type	Date	Date Unknown
Release	Nov 9, 2012
Reset	Dec 17, 2012
Release	May 18, 2015
Reset	Jun 5, 2015

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 9, 2012			Dec 17, 2012
May 18, 2015