Computed Tomography Coronary Angiography (CTCA) Prior to Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI) - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Primary Outcome
研究概览
简要总结
A Chronic Total Occlusion or CTO of a coronary artery is a an artery that has been blocked for >/= 3 months. More than a decade ago, patients with such coronary artery blockage would have been sent for Coronary Artery Bypass Graft (CABG) surgery. Newer tools and techniques have facilitated the opening (angioplasty or percutaneous coronary intervention (PCI)) of such occluded arteries- however success is not 100% unlike in simple coronary blockages.
Computed Tomography Coronary Angiography (CTCA) identifies the artery path and characteristics of the CTO including calcification - the latter many times is the reason for failure to cross the CTO.
The investigators aim to conduct a feasibility study to assess the effectiveness of CTCA prior to CTO PCI by randomizing suitable CTO patients to CTCA or direct CTO PCI.
20 patients will be randomized 1:1 using the sealed envelope technique and compared for:
Primary endpoint:
CTO PCI success rate in CTCA arm versus no CTCA arm
Secondary endpoints:
i. Angina by the Seattle Angina Questionnaire (SAQ) at 6 months (range 0-100, lower score worse, higher scores better, based on 5 characteristics - severity, frequency, treatment satisfaction and quality of life scores).
ii. Compare the number of patients who required a second CTO PCI procedure in the CTCA arm versus no CTCA arm iii. Procedural differences between the intervention CTCA arm versus no CTCA arm including: Health Economics: Cost saved per patient due to improved success and reduction in readmission or further procedure CTO PCI efficiency: Wire crossing time, Procedure time CTO PCI safety outcomes: Procedural complications (Ellis perforation, tamponade, acute kidney injury/contrast induced nephropathy, access site bleeding, donor vessel injury), Radiation: CTCA dose, CTO PCI dose, and combined CTCA and CTO PCI dose. Contrast: CTCA volume, CTO PCI volume, and combined CTCA and CTO PCI volume Change in CTO PCI strategy hierarchy as a result of the CTCA review
Patients will have a telephonic follow up at 6 months to assess angina ( by the Seattle Angina Questionnaire)
详细描述
Computed Tomography Coronary Angiography (CTCA) prior to Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI) - a feasibility study
Summary of Trial design:
Randomised, prospective, single centre feasibility study of CTCA prior to CTO PCI
Site and Chief Investigator:
Sandwell and West Birmingham NHS Trust, Birmingham, United Kingdom Vinoda Sharma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •≥18 years
- •CTO with J-CTO score≥2
- •Appropriate indication for CTO PCI
- •Adequate CTCA images for analysis
排除标准
- •<18 years of age
- •CTO with J-CTO score<2
- •Inadequate/degraded CTCA images
- •Pregnant/lactating women
- •Patients with severe contrast allergy
- •Patients unable to provide written informed consent
结局指标
主要结局
Primary Outcome
时间窗: 24 hours = Day 0 of the index CTO PCI procedure
CTO PCI success rate in CTCA arm versus no CTCA arm
次要结局
- i. Angina(6 months)
- ii. More than one CTO PCI procedure required(24 hours = Day 0 of the index CTO PCI procedure)
- iv. Procedural differences between the intervention CTCA arm versus no CTCA arm-CTO PCI wire crossing time(24 hours = Day 0 of the index CTO PCI procedure)
- iii. Procedural differences between the intervention CTCA arm versus no CTCA arm-health economics(One year = At the end of the study)
- v. Procedural differences between the intervention CTCA arm versus no CTCA arm-CTO PCI total procedure time(24 hours = Day 0 of the index CTO PCI procedure)
- vi. CTO PCI safety outcomes: Procedural complications (Ellis perforation, tamponade, acute kidney injury/contrast induced nephropathy, access site bleeding, donor vessel injury)(24 hours = Day 0 of the index CTO PCI procedure except acute kidney injury which will be based on blood tests 48 hours after completion of the procedure)
- vii. CTO PCI safety outcomes: Radiation: CTCA dose, CTO PCI dose, and combined CTCA and CTO PCI dose(24 hours = Day 0 of the index CTO PCI procedure)
- viii. CTO PCI safety outcomes: Contrast: CTCA volume, CTO PCI volume, and combined CTCA and CTO PCI volume(24 hours = Day 0 of the index CTO PCI procedure)
- ix. Change in CTO PCI strategy hierarchy as a result of the CTCA review : Initial procedure strategy in planning versus actual initial and final procedure strategy(24 hours = Day 0 of the index CTO PCI procedure)
研究者
Vinoda Sharma
Consultant Interventional Cardiologist
Sandwell & West Birmingham Hospitals NHS Trust