- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02513108
Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study) (SPEEDY)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rogaland
-
Stavanger, Rogaland, Norway, 4056
- Stavanger University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
Angiographic
- No-reflow/slow flow post PCI
- Sub-optimal PCI result
- Dissection type C-E
- Rest dissection after stent deployment
- Angiographic thrombus
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: same day discharge
patients discharged same day after uncomplicated PCI
|
same day discharge after PCI for stable CAD
|
No Intervention: standard care
standard care where patients are discharged the day after procedure after adequate observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of complications (access site bleeding)
Time Frame: 1 month
|
observation of complications requiring intervention
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nigussie Bogale, M.D, PhD, Helse Stavanger HF
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUS2015NIBO01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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