NCT01759043已完成不适用
Safety and Feasibility of Using a Single Transradial Guiding Catheter for Both Left and Right Coronary Angiography and Intervention in Patients With ST-segment Myocardial Infarction(RAPID)
Beijing Luhe Hospital2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Cath Lab door to balloon time (C2B)
研究概览
简要总结
The Rapid Trial is a randomized-controlled trial proposed to test the hypothesis that using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI) can reduce procedure time, fluoroscopy time and Cath Lab door to balloon(C2B) time when compared with traditional approach which first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.
详细描述
- background: Coronary intervention using transradial approach is common worldwide. It is normally necessary to use one diagnostic catheter and guiding catheter in primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). It is unknown whether using a single guiding catheter for both nonculprit and culprit vessel angiography and intervention during transradial primary percutaneous coronary intervention (PCI) is feasible.
- objective:The aim of this study is to investigate the feasibility of using a single guiding catheter for left and right coronary angiography and intervention in patients with ST elevation myocardial infarction (STEMI).
- This was a single-center, prospective, randomized study,patients with STEMI indicated for transradial primary PCI were randomized into two groups : group I consisted of patients who underwent coronary angiography and primary PCI by using a single guiding catheter.GroupII included patients who first underwent coronary angiography with diagnostic catheter followed by guiding catheter selection for intervention.
- the primary Endpoints
a.Cath Lab door to balloon time (C2B) 5. the Secondary endpoints:
- Occurrence of major adverse cardiac events (MACE) during 6 months
- Cardiac death
- Target vessel related myocardial infarction
- Ischemia driven Target Vessel Revascularization (TVR)
- Ischemia driven Target Lesion Revascularization (TLR)
- Definite / probable stent thrombosis by ARC definition
- Number of catheters and wires used
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)
- door to balloon time
- contrast consumption
- procedure time
- fluoroscopy time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patient must be > 18 years of age.
- •Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
- •Symptoms ≥ 30 min and ≤12 hours
- •Patient and treating interventional cardiologist agree for randomization.
- •Patient provides written informed consent.
- •Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
- •Palpable radial or ulnar artery
- •Previous experience of the operator with at least 100 cases of radial artery access within the past year
排除标准
- •Concurrent participation in other investigational study
- •Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
- •Absence of radial or ulnar artery pulsation
- •Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
- •Uncontrolled hypertension
- •Prior CABG surgery
- •Fibrinolytic therapy for current MI treatment
- •patient have a life expectancy of <180days
结局指标
主要结局
Cath Lab door to balloon time (C2B)
时间窗: 24hours
次要结局
- major adverse cardiac events (MACE)(180days)
- Number of catheters and wires used(24hours)
- contrast consumption(24hours)
- procedure time(24hours)
- fluoroscopy time(24hours)
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arteriovenous fistula formation, dissection, limb ischemia, bleeding)(30days)
- door to balloon time(24hours)
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingNCT02427776Imcyse SA2
Unknown
1 期
Clinical Study to Evaluate the Safety and Feasibility of spCART-269 Injection in the Treatment of MMMultiple MyelomaNCT04500431Shanghai Tongji Hospital, Tongji University School of Medicine10
已完成
1 期
MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)Human Immunodeficiency VirusNCT05494736Merck Sharp & Dohme LLC20
已完成
不适用
Feasibility Trial of ValenTx Endo Bypass System of the ValenTx Endo Bypass System in Obese SubjectsObesityNCT01207830ValenTx, Inc.10
撤回
1 期
Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast CancerBreast CancerNCT05634954GE Healthcare12