The Acute Coronary Syndrome Study (ACS)
Primary Purpose
Acute Coronary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Early discharge
Care as usual. No intervention. (Control group)
Sponsored by
About this trial
This is an interventional health services research trial for Acute Coronary Syndrome focused on measuring Cost analysis, Safety, Length of stay, Randomized controlled trials, Early discharge
Eligibility Criteria
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.
Sites / Locations
- Oslo University Hospital, UllevaalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1 Fast Track Group
Group 2: Ordinary care
Arm Description
The patients are discharged the same day after coronary angiography to the refering Hospital
Ordinary Cardiology care in the Intervention hospital
Outcomes
Primary Outcome Measures
Cost effectiveness. Adverse medical events
Secondary Outcome Measures
SF-36
Full Information
NCT ID
NCT01027026
First Posted
December 4, 2009
Last Updated
December 4, 2009
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01027026
Brief Title
The Acute Coronary Syndrome Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Cost analysis, Safety, Length of stay, Randomized controlled trials, Early discharge
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Fast Track Group
Arm Type
Experimental
Arm Description
The patients are discharged the same day after coronary angiography to the refering Hospital
Arm Title
Group 2: Ordinary care
Arm Type
Active Comparator
Arm Description
Ordinary Cardiology care in the Intervention hospital
Intervention Type
Other
Intervention Name(s)
Early discharge
Intervention Description
The patients are discharged the same day as coronary angiography.
Intervention Type
Other
Intervention Name(s)
Care as usual. No intervention. (Control group)
Intervention Description
The patients are admitted and cared as usual in cardiology ward.
Primary Outcome Measure Information:
Title
Cost effectiveness. Adverse medical events
Time Frame
30 days and a year's events
Secondary Outcome Measure Information:
Title
SF-36
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Odd Johansen, ph.d MD
Phone
+47 22 11 91 92
Email
odjo@uus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Jack Gunnar Andersen, Master of Management
Phone
+47 98 64 16 34
Email
jaga@uus.no
Facility Information:
Facility Name
Oslo University Hospital, Ullevaal
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odd Johansen, ph. d MD
Phone
+47 22 11 93 81
Email
odjo@uus.no
First Name & Middle Initial & Last Name & Degree
Jack Gunnar Andersen, Master of Management
Phone
+47 98 64 16 34
Email
jaga@uus.no
First Name & Middle Initial & Last Name & Degree
Jack Gunnar Andersen, Master of Management
12. IPD Sharing Statement
Learn more about this trial
The Acute Coronary Syndrome Study
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