The Acute Coronary Syndrome Study

Acute Coronary Syndrome Clinical Trial

— ACS  

Official title:

The Acute Coronary Syndrome Study. Organization and Treatment of Patients With Acute Coronary Syndrome, With a Focus on Costs, Organization and Security

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01027026
• Other study ID #: REK: 6.2008.1724
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2009
• Last updated: December 4, 2009
• Start date: February 2009
• Est. completion date: May 2013

Study information

• Verified date: December 2009
• Source: Ullevaal University Hospital
• Contact: Odd Johansen, ph.d MD
• Phone: +47 22 11 91 92
• Email: odjo[@]uus.no
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The topic of this study is whether patients with Acute coronary syndrome (ACS)may can be transferred to their refering hospital same day that they arrived intervention hospital.

This is to see if one can reduce the hospital stay and costs for the intervention center, and the total hospitalization time.

and this rapid transport not give more medical complications

Our 1 hypothesis is that patients with ACS, who are transported back to the refering hospital the same day, will reduce the length of stay in intervention center without an increase for the stay at the refering hospital.

Our 2 hypothesis is that patients with ACS, who are transported back to the refering hospital the same day as the treatment is performed, have no more complications than those who stay overnight in the intervention hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2013
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Other:
• Early discharge
The patients are discharged the same day as coronary angiography.
• Care as usual. No intervention. (Control group)
The patients are admitted and cared as usual in cardiology ward.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevaal	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost effectiveness. Adverse medical events		30 days and a year's events	Yes
Secondary	SF-36		One year	Yes