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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: same day discharge

• Registration Number: NCT02513108
• Lead Sponsor: Helse Stavanger HF

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.

Study Timeline

• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Study Start: 2015-12
• Status Verified: 2018-04
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
same day discharge	same day discharge	patients discharged same day after uncomplicated PCI

Primary Outcome Measures

Name	Time	Method
number of complications (access site bleeding)	1 month	observation of complications requiring intervention

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Rogaland, Norway