The Acute Coronary Syndrome Study (ACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT01027026
First received: December 4, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Cost effectiveness. Adverse medical events [ Time Frame: 30 days and a year's events ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027026

Contacts
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

Locations
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         
Sponsors and Collaborators
Ullevaal University Hospital
  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 July 23, 2014