Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Helse Stavanger HF
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- number of complications (access site bleeding)
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
original sample size calculation is amended from 151 patients to 82 patients after recalculation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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
Arms & Interventions
same day discharge
patients discharged same day after uncomplicated PCI
Intervention: same day discharge (Procedure)
standard care
standard care where patients are discharged the day after procedure after adequate observation
Outcomes
Primary Outcomes
number of complications (access site bleeding)
Time Frame: 1 month
observation of complications requiring intervention
Secondary Outcomes
No secondary outcomes reported