The Acute Coronary Syndrome Study (ACS)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome |
Other: Early discharge Other: Care as usual. No intervention. (Control group) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | The Acute Coronary Syndrome Study. Organization and Treatment of Patients With Acute Coronary Syndrome, With a Focus on Costs, Organization and Security |
- Cost effectiveness. Adverse medical events [ Time Frame: 30 days and a year's events ] [ Designated as safety issue: Yes ]
- SF-36 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 Fast Track Group
The patients are discharged the same day after coronary angiography to the refering Hospital
|
Other: Early discharge
The patients are discharged the same day as coronary angiography.
|
|
Active Comparator: Group 2: Ordinary care
Ordinary Cardiology care in the Intervention hospital
|
Other: Care as usual. No intervention. (Control group)
The patients are admitted and cared as usual in cardiology ward.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Odd Johansen, ph.d MD | +47 22 11 91 92 | odjo@uus.no |
| Contact: Jack Gunnar Andersen, Master of Management | +47 98 64 16 34 | jaga@uus.no |
| Norway | |
| Oslo University Hospital, Ullevaal | Recruiting |
| Oslo, Norway, 0407 | |
| Contact: Odd Johansen, ph. d MD +47 22 11 93 81 odjo@uus.no | |
| Contact: Jack Gunnar Andersen, Master of Management +47 98 64 16 34 jaga@uus.no | |
| Principal Investigator: Jack Gunnar Andersen, Master of Management | |
More Information
No publications provided
| Responsible Party: | Bilde og Intervensjonsklinikken Radiologi og Nukleaermedisin, Ullevaal University Hospital |
| ClinicalTrials.gov Identifier: | NCT01027026 History of Changes |
| Other Study ID Numbers: | REK: 6.2008.1724 |
| Study First Received: | December 4, 2009 |
| Last Updated: | December 4, 2009 |
| Health Authority: | Norway: Ethics Committee |
Keywords provided by Ullevaal University Hospital:
|
Cost analysis Safety Length of stay Randomized controlled trials Early discharge |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013