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

Helse Stavanger HF

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: same day discharge

Study type: Interventional

Funder types: Other

Identifiers

NCT02513108

SUS2015NIBO01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

same day discharge

Active Comparator group

Description:

patients discharged same day after uncomplicated PCI

Treatment:

Procedure: same day discharge

standard care

No Intervention group

Description:

standard care where patients are discharged the day after procedure after adequate observation