Acute Coronary SyndromeACSNCT01027026
The Acute Coronary Syndrome Study
A study testing Early discharge in people with Acute Coronary Syndrome, run by Ullevaal University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Early discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2009to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with acute coronary syndrome who are referred from other hospitals
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital, Ullevaal
Oslo, 0407
Odd Johansen, ph. d MD, +47 22 11 93 81, odjo@uus.no
Jack Gunnar Andersen, Master of Management, +47 98 64 16 34, jaga@uus.no
About this study
Official title: The Acute Coronary Syndrome Study. Organization and Treatment of Patients With Acute Coronary Syndrome, With a Focus on Costs, Organization and Security
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Early discharge, Care as usual. No intervention. (Control group)
- Keywords
- Cost analysis, Safety, Length of stay, Randomized controlled trials, Early discharge
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early dischargeOther
The patients are discharged the same day as coronary angiography.
Care as usual. No intervention. (Control group)Other
The patients are admitted and cared as usual in cardiology ward.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Fast Track Group | Experimental | The patients are discharged the same day after coronary angiography to the refering Hospital Receives: Other: Early discharge |
| Group 2: Ordinary care | Active comparator | Ordinary Cardiology care in the Intervention hospital Receives: Other: Care as usual. No intervention. (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost effectiveness. Adverse medical events
Measured: 30 days and a year's events
Secondary outcomes (1)
SF-36
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027026
- Sponsor's protocol ID
- REK: 6.2008.1724
- Acronym
- ACS
- Status last verified
- Dec 2009
- First submitted
- 4 Dec 2009
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Coronary Syndrome Study. Organization and Treatment of Patients With Acute Coronary Syndrome, With a Focus on Costs, Organization and Security
- ClinicalTrials.gov ID
- NCT01027026
- Acronym / sponsor ID
- ACS / REK: 6.2008.1724
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cost analysis, Safety, Length of stay, Randomized controlled trials, Early discharge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Fast Track Group | Experimental | Other: Early dischargeThe patients are discharged the same day after coronary angiography to the refering Hospital |
| Group 2: Ordinary care | Active comparator | Other: Care as usual. No intervention. (Control group)Ordinary Cardiology care in the Intervention hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with acute coronary syndrome who are referred from other hospitals
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early dischargeThe patients are discharged the same day as coronary angiography. | Other | Group 1 Fast Track Group |
| Care as usual. No intervention. (Control group)The patients are admitted and cared as usual in cardiology ward. | Other | Group 2: Ordinary care |
Primary outcome
Cost effectiveness. Adverse medical events
Time frame: 30 days and a year's events
1 secondary outcome
SF-36
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early discharge in people with Acute Coronary Syndrome, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odd Johansen, ph.d MD (+47 22 11 91 92, odjo@uus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost effectiveness. Adverse medical events (time frame: 30 days and a year's events). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2009.