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Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)

Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02513108
Acronym
SPEEDY
Enrollment
82
Registered
2015-07-31
Start date
2015-12-31
Completion date
2018-11-30
Last updated
2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

same day discharge after PCI for stable CAD

Sponsors

Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

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

Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
number of complications (access site bleeding)1 monthobservation of complications requiring intervention

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026