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

Coronary Artery Disease Clinical Trial

— SPEEDY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513108
• Other study ID #: SUS2015NIBO01
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: November 2018

Study information

• Verified date: April 2018
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• same day discharge
same day discharge after PCI for stable CAD

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger	Rogaland

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of complications (access site bleeding)	observation of complications requiring intervention	1 month