Coronary Artery DiseaseSPEEDYNCT02513108
Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
A study testing same day discharge in people with Coronary Artery Disease, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The purpose of this study is to provide information on safety of same day discharge after uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- same day discharge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2015to Nov 2018
- 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
- Elective procedures Monday through Thursday
- Patient consenting for same day discharge
- Operator has assessed the patient and is in agreement
- Adequate observational facility
- Uncomplicated procedure
- Acceptable social network at home
- Uneventful post PCI ECG
- Adequate hemostasis of puncture site
Who cannot join
- Angiographic
- No-reflow/slow flow post PCI
- Sub-optimal PCI result
- Dissection type C-E
- Rest dissection after stent deployment
- Angiographic thrombus
Show all 19Show fewer
- Guidewire perforation
- Clinical
- Advanced age
- Severe renal failure (GFR < 30ml/min)
- Excessive bleeding risk
- Symptomatic heart failure
- Severe visual or hearing impairment
- Multi-vessel PCI (2 main vessels or left main)
- Use of GP IIb/IIIa inhibitors
- Social
- Living alone or has no telephone
- Long driving distance (> 30-45 min)
- Patient/next to keen can´t communicate with health personnel without a translator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to provide information on safety of same day discharge after uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian clinical practice. The investigators also think that is in patients interest to stay as short time as possible in hospital and this will be measured using standardised quality of life questionnaires.
Read the detailed description
The international literature has already provided documentation on the safety of same day discharge in various clinical scenario. In this particular study, the investigators focus on challenging the contemporary Norwegian practice where every body stays over night.
Only patients with stable angina pectoris will be included in the study. After informed consent and successful procedure, the patients will be randomised to same day discharge or standard care. Same day discharge patients will be contacted by telephone the day after the procedure for follow-up conversation with particular emphasis on access site complications.
Both groups will receive quality of life questionnaire within a month for assessment of difference between the two strategies.
- Conditions
- Coronary Artery Disease
- Being tested
- same day discharge
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
same day dischargeProcedure or surgery
same day discharge after PCI for stable CAD
| Study group | Role | What they receive |
|---|---|---|
| same day discharge | Active comparator | patients discharged same day after uncomplicated PCI Receives: Procedure: same day discharge |
| standard care | No intervention | standard care where patients are discharged the day after procedure after adequate observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of complications (access site bleeding)
observation of complications requiring intervention
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nigussie Bogale, M.D, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513108
- Sponsor's protocol ID
- SUS2015NIBO01
- Acronym
- SPEEDY
- Status last verified
- Apr 2018
- First submitted
- 17 Jul 2015
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
- ClinicalTrials.gov ID
- NCT02513108
- Acronym / sponsor ID
- SPEEDY / SUS2015NIBO01
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 31 Jul 2015 (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 purpose of this study is to provide information on safety of same day discharge after uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian clinical practice. The investigators also think that is in patients interest to stay as short time as possible in hospital and this will be measured using standardised quality of life questionnaires.
Detailed description
The international literature has already provided documentation on the safety of same day discharge in various clinical scenario. In this particular study, the investigators focus on challenging the contemporary Norwegian practice where every body stays over night.
Only patients with stable angina pectoris will be included in the study. After informed consent and successful procedure, the patients will be randomised to same day discharge or standard care. Same day discharge patients will be contacted by telephone the day after the procedure for follow-up conversation with particular emphasis on access site complications.
Both groups will receive quality of life questionnaire within a month for assessment of difference between the two strategies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| same day discharge | Active comparator | Procedure: same day dischargepatients discharged same day after uncomplicated PCI |
| standard care | No intervention | –standard care where patients are discharged the day after procedure after adequate observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Elective procedures Monday through Thursday
- Patient consenting for same day discharge
- Operator has assessed the patient and is in agreement
- Adequate observational facility
- Uncomplicated procedure
Key exclusion criteria (19 listed)
- Angiographic
- Clinical
- Social
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 |
|---|---|---|
| same day dischargesame day discharge after PCI for stable CAD | Procedure or surgery | same day discharge |
Primary outcome
number of complications (access site bleeding)
Time frame: 1 month
observation of complications requiring intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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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.
Nigussie Bogale, M.D, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing same day discharge in people with Coronary Artery Disease, run by Helse Stavanger HF 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 1 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of complications (access site bleeding) (time frame: 1 month). 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 1 May 2019; AzTrials last refreshed its copy on 4 Nov 2026.