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

NCT ID: NCT02513108

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-11-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

same day discharge

patients discharged same day after uncomplicated PCI

Group Type: ACTIVE_COMPARATOR

same day discharge

Intervention Type: PROCEDURE

same day discharge after PCI for stable CAD

standard care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

same day discharge

same day discharge after PCI for stable CAD

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nigussie Bogale, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Stavanger University Hospital

Stavanger, Rogaland, Norway

Countries

Norway

Other Identifiers

SUS2015NIBO01

Identifier Type: -

Identifier Source: org_study_id