Safety and Feasibility of Same-Day Discharge After Elective Transradial Percutaneous Coronary Intervention: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Composite of major adverse clinical events
研究概览
简要总结
This single-center pilot randomized trial evaluated the safety and feasibility of same-day discharge (within 6 hours) compared with conventional overnight hospitalization (≥24 hours) in patients with chronic coronary artery disease undergoing successful elective transradial PCI in a Brazilian public tertiary center. Participants were followed by structured telemedicine consultation at 7 days.
详细描述
Adults (≥18 years) with chronic CAD scheduled for elective transradial PCI were screened. After successful PCI and confirmation of eligibility, participants were randomized 1:1 (computer-generated sequence; allocation concealment via sequentially numbered opaque sealed envelopes) to same-day discharge (≤6 h, minimum 3 h monitoring with clinical assessment, ECG and radial access evaluation) or conventional hospitalization (≥24 h). Follow-up was performed by an outcome assessor blinded to allocation via structured 7-day telemedicine consultation. Pilot/feasibility design; the full confirmatory trial targets 232 participants (116/group).
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
- Single (Outcomes Assessor)
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
- •Adults ≥18 with chronic CAD undergoing successful elective transradial PCI; written informed consent.
排除标准
- •LVEF ≤40%; MI within 14 days; creatinine clearance ≤45 mL/min; hemoglobin ≤10 g/dL; platelets ≤100,000/µL; INR >1.5; allergy to aspirin, clopidogrel, or iodinated contrast; procedural (angiographic or clinical) complications; access-site complications requiring prolonged monitoring.
研究组 & 干预措施
Same-Day Discharge
discharge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up.
干预措施: same day discharge (Behavioral)
Conventional Hospitalization
overnight stay ≥24 h per institutional protocol.
干预措施: Conventional Hospitalization (Behavioral)
结局指标
主要结局
Composite of major adverse clinical events
时间窗: 7 days after PCI
All-cause death, myocardial infarction, unplanned revascularization, stroke, hospital readmission, or major bleeding (BARC ≥3)
次要结局
- Emergency department visits(7 days after PCI)
- Recurrent chest pain(7 days after PCI)
- Radial access-site complications(7 days after PCI)
研究者
PAULO CASTRO CHERPAK
Principal Investigator
University of Pernambuco