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Completed

NCT Number: NCT02513108

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stavanger University Hospital

Stavanger, Rogaland, 4056, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Same day discharge

Procedure

same day discharge after PCI for stable CAD

Primary outcomes

  1. number of complications (access site bleeding)

    Time frame: 1 month

    observation of complications requiring intervention

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Acronym: SPEEDY

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2015
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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