Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Number of patients with successful CTO PCI procedure in both groups
研究概览
简要总结
The chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. With this study, the investigators want to adress the impact of CT scan performed before the surgical procedure. A better knowledge of the patient's anatomy could lead to a better success rate of the operation, with a lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.
详细描述
A chronic total occlusion (CTO) is the complete obstruction of a coronary artery that has been established from more than 3 months with TIMI (Thrombolysis in Myocardial Infarction) 0 flow. This is a frequent pathology, demonstrated in 20% of patients studied with a coronary angiography. The patients affected by an isolated CTO or by a multi-vascular coronary disease with one or more CTO are an heterogenous population in relation to age, co-morbidity, risk factors.
The treatment of this disease is medical, interventional or surgical. The interventional option is often the first choice in case of symptoms or ischemia associated with viability of the myocardial wall, originally perfused by the occluded segment. Medical treatment is often not enough to reduce symptoms and to improve quality of life. Surgery is very invasive, especially for patients with mono-vascular disease, not always possible, especially in case of distal diffuse disease or heavy co-morbidity.
The Percutaneous Coronary Intervention (PCI) is a good option thanks to the improvement of materials and recanalization techniques (anterograde, retrograde and dissection re-entry). However, the procedure is often long, expensive, using a lot of contrast medium and X ray.
At the diagnosis stage of a CTO, the Japan Chronic Total Occlusion (J-CTO) score defines the complexity of the procedure : 0 easy, 1 intermediate, 2 hard, ≥ 3 very hard. The score is actually calculated with the angiography data after evaluation of the occlusion's proximal cap shape, presence of calcifications in the occluded segment, tortuosity of the occluded segment and length of the occlusion.
In addition to the angiography data, a CT scan of coronary artery can be performed as part of Standard of Care. In the study's coordinating center, more than 2000 CT scans are performed by the team of interventional cardiologists. Data generated from last generation CT scan are then interpreted to extrapolate informations about the occluded segment, the occluded artery and the contralateral artery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years old and ≤ 90 years old,
- •BMI ≤ 40 kg/m²,
- •Dated and signed informed consent, before any study-related procedures
- •Ability to understand and comply with the study procedures,
- •Affiliate or recipient of a social security scheme,
- •Coronary artery chronic total occlusion (TIMI 0 flow from > 3 months) associated with myocardial viability (intended like normokinetic/hypokinetic wall motion or instrumental data in favor of viability) associated with ≥ CCS2 angina or ≥ NHYA2 dyspnea or documented ischemia or ejection fraction <50%.
- •Coronary angiography J-CTO score ≥ 2 (complex cases)
排除标准
- •Pregnant or breastfeeding woman,
- •Adults patients protected by law,
- •Very frequent and irregular cardiac rhythm (>100/min.),
- •More than one CTO to be treated by PCI,
- •Coronary angiography J-CTO (Japan Chronic Total Occlusion) score 0/1
- •Hemodynamic instability,
- •Anemia < 9g/dl,
- •Gastrointestinal bleeding,
- •Thrombocytopenia with < 50 000/mm3 platelets count,
- •Severe valvular disease associated
- •CT-Scan performed as part of the standard of care pathology diagnosis, before the inclusion
结局指标
主要结局
Number of patients with successful CTO PCI procedure in both groups
时间窗: Immediately after surgery.
TIMI 3 flow restoration and residual stenosis \< 30%, by wire crossing in less than (≤) 60 minutes guidewire manipulation. TIMI flow and residual stenosis will be evaluated by a pool of 2 cardiologists not involved in the procedure and blinded regarding the randomized group.
次要结局
- Total time of CTO PCI procedure(Immediately after surgery.)
- Volume of iodine contrast medium used for the CTO PCI procedure(Immediately after surgery.)
- Rate of CTO PCI complications(6 months starting from the date of the surgery.)
- Radiation level used during the CTO PCI procedure(Immediately after surgery.)
- Safety assessed with Adverse Events reporting(6 months starting from the date of the surgery.)
- Angina and dyspnea(6 months starting from the date of the inclusion.)
- Cost of the the CTO PCI procedure(Immediately after surgery.)
- Major Adverse Cardiac Events(6 months starting the date of the inclusion.)
- renal failure collection(6 months starting the date of the inclusion.)
- CK measure(24 hours after surgery)
- Creatinine level before discharge(24 hours after surgery)
- Troponin measure(24 hours after surgery)
- Hemoglobin measure(24 hours after surgery)
- clearance of creatinine measure(24 hours after surgery)
- Creatinine measure(24 hours after surgery)