NCT01068119终止4 期
Feasibility and Safety of Same-Day Discharge of Troponin Negative Patients After Coronary PTCA Via the Transfemoral Approach
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Number of cardiac MACE, major cerebral events, and groin complications
研究概览
简要总结
Same day discharge is safe and feasible in selected troponin negative patients undergoing coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral approach.
详细描述
The feasibility and safety of same day discharge post PCI will be examined. Study data will be compared to national registries and national or regional databases of PCI in Troponin negative patients with overnight stay. As part of the registry we will also assess compliance with dual antiplatelet therapy at six months and at 1 year and will record any reasons for premature discontinuation as well as any associated adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Scheduled for catheterization/coronary angiography
- •Undergoing diagnostic coronary angiography to define the coronary anatomy with the intent for revascularization (ad-hoc PCI) or planned PCI to define the coronary anatomy with the intent for revascularization due to one of the following:
- •exertional or rest chest pain (or angina equivalent)
- •abnormal Exercise Stress Test
- •abnormal nuclear tests
- •abnormal pharmacologic or stress echocardiogram, or pharmacologic MRI
- •abnormal EKGs
- •abnormal Calcium scores
- •abnormal coronary CT angiogram
- •Ability and willingness to consent and Authorization for use of PHI
排除标准
- •ACS (STEMI, UA/NSTEMI)
- •Positive Troponin I per local laboratory standards
- •Known EF<30%
- •GFR<50% (calculation using the IDMS-Traceable MDRD study equation
- •Dye Allergy that unable to be safely premedicated
- •Known current or history of bleeding diathesis
- •Current or anticipated treatment with warfarin, oral factor Xa inhibitor, oral direct thrombin inhibitor, LMWH, or TNK
- •Known platelet count <100,000/mm³ or known INR >1.5 at time of enrollment
- •Hgb <10 g/dL and/or Hct < 30%
- •Residence >60 minutes from the hospital
- •Reliable caregiver not available for home post PCI recovery
- •Participation in another study that would require hospital procedures or test post PCI prior to discharge
- •Inability or unwillingness to consent for study, follow up procedures and Authorization for use of PHI
- •Physician clinical determination participant is not suitable for study participation
结局指标
主要结局
Number of cardiac MACE, major cerebral events, and groin complications
时间窗: 6, 12, and 18 months post study initation
次要结局
- Rate of compliance with dual antiplatelet therapy(6, 12 , and 18 months post study initiation)
研究者
研究点 (2)
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