search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
same day discharge
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stavanger University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

same day discharge

standard care

Arm Description

patients discharged same day after uncomplicated PCI

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

Outcomes

Primary Outcome Measures

number of complications (access site bleeding)
observation of complications requiring intervention

Secondary Outcome Measures

Full Information

First Posted
July 17, 2015
Last Updated
April 29, 2019
Sponsor
Helse Stavanger HF
search

1. Study Identification

Unique Protocol Identification Number
NCT02513108
Brief Title
Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
Acronym
SPEEDY
Official Title
Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
original sample size calculation is amended from 151 patients to 82 patients after recalculation
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
same day discharge
Arm Type
Active Comparator
Arm Description
patients discharged same day after uncomplicated PCI
Arm Title
standard care
Arm Type
No Intervention
Arm Description
standard care where patients are discharged the day after procedure after adequate observation
Intervention Type
Procedure
Intervention Name(s)
same day discharge
Intervention Description
same day discharge after PCI for stable CAD
Primary Outcome Measure Information:
Title
number of complications (access site bleeding)
Description
observation of complications requiring intervention
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigussie Bogale, M.D, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4056
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs