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

Study 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.

Official Title
-----------------
Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: same day discharge


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: same day discharge<br>patients discharged same day after uncomplicated PCI | Procedure: same day discharge<br>* same day discharge after PCI for stable CAD<br>|
| No Intervention: standard care<br>standard care where patients are discharged the day after procedure after adequate observation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complications (access site bleeding) | observation of complications requiring intervention | 1 month |