Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- number of complications (access site bleeding)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
original sample size calculation is amended from 151 patients to 82 patients after recalculation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Angiographic
- •No-reflow/slow flow post PCI
- •Sub-optimal PCI result
- •Dissection type C-E
- •Rest dissection after stent deployment
- •Angiographic thrombus
- •Guidewire perforation
- •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
- •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
研究组 & 干预措施
same day discharge
patients discharged same day after uncomplicated PCI
干预措施: same day discharge (Procedure)
standard care
standard care where patients are discharged the day after procedure after adequate observation
结局指标
主要结局
number of complications (access site bleeding)
时间窗: 1 month
observation of complications requiring intervention
次要结局
未报告次要终点