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Clinical Trials/NCT02513108
NCT02513108
Completed
Not Applicable

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

Helse Stavanger HF1 site in 1 country82 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Helse Stavanger HF
Enrollment
82
Locations
1
Primary Endpoint
number of complications (access site bleeding)
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
November 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

number of complications (access site bleeding)

Time Frame: 1 month

observation of complications requiring intervention

Study Sites (1)

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