Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
SPEEDY
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Dec 2015
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMay 1, 2019
April 1, 2018
2.9 years
July 17, 2015
April 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
number of complications (access site bleeding)
observation of complications requiring intervention
1 month
Study Arms (2)
same day discharge
ACTIVE COMPARATORpatients discharged same day after uncomplicated PCI
standard care
NO INTERVENTIONstandard care where patients are discharged the day after procedure after adequate observation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stavanger University Hospital
Stavanger, Rogaland, 4056, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nigussie Bogale, M.D, PhD
Helse Stavanger HF
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- original sample size calculation is amended from 151 patients to 82 patients after recalculation
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 31, 2015
Study Start
December 1, 2015
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
May 1, 2019
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share