NCT01027026

Brief Summary

The investigators will make a prospective study in which they will look at the economics and security of the treatment of patients with acute coronary syndrome. The investigators want to do a randomized trial. One group will be treated as they have been treated at Ullevål University Hospital (UUS) in recent years, and the other group will be returned to their refering hospital the same day. The objective of this study will be to provide increased knowledge about whether the rapid discharge from the intervention center is associated with differences in costs or security.

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

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, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

December 4, 2009

Last Update Submit

December 4, 2009

Conditions

Keywords

Cost analysisSafetyLength of stayRandomized controlled trialsEarly discharge

Outcome Measures

Primary Outcomes (1)

  • Cost effectiveness. Adverse medical events

    30 days and a year's events

Secondary Outcomes (1)

  • SF-36

    One year

Study Arms (2)

Group 1 Fast Track Group

EXPERIMENTAL

The patients are discharged the same day after coronary angiography to the refering Hospital

Other: Early discharge

Group 2: Ordinary care

ACTIVE COMPARATOR

Ordinary Cardiology care in the Intervention hospital

Other: Care as usual. No intervention. (Control group)

Interventions

The patients are discharged the same day as coronary angiography.

Group 1 Fast Track Group

The patients are admitted and cared as usual in cardiology ward.

Group 2: Ordinary care

Eligibility Criteria

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

You may qualify if:

  • All patients with acute coronary syndrome who are referred from other hospitals

You may not qualify if:

  • Patients younger than 18years.
  • Known mental retardation, dementia or harmful use of alcohol or drugs.
  • Allergy or intolerance to ASA and / or clopidogrel.
  • Patients who have previously been involved in this study.
  • Acute STEMI infarction for less than 72 hours ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Odd Johansen, ph.d MD

CONTACT

Jack Gunnar Andersen, Master of Management

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 7, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2010

Study Completion

May 1, 2013

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations