The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
研究概览
简要总结
Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.
详细描述
Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •age >18 years old
- •single CTO lesions, or other stenosis have been PCI treated for more than one months
- •the diameter of target vessel ≥2.5mm
- •stable angina pectoris, or myocardial ischemia in the area of CTO lesions
- •the patients agree to this research plan and sign the consent form, and complete the follow-up
排除标准
- •Acute myocardial infarction in one month
- •In addition to the area of CTO lesions, there are serious untreated coronary lesions
- •bridge vascular CTO lesions
- •untreated coronary artery or cardiac surgery due to interventional complications, or intraoperative death
- •acute decompensated heart failure
- •allergies to contrast or radionuclide tracers
- •patients with planned pregnancies or lactation or 1 years after intervention
- •malignant neoplasms or life expectancy of less than 1 years
- •patients plan of surgery
- •patients cannot tolerate double antiplatelet therapy for at least 12 months
- •any condition that does not fit coronary intervention or is a drug-eluting stent
结局指标
主要结局
Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
时间窗: one year
Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
score of Seattle angina questionnaire
时间窗: one year
the result of Seattle angina questionnaire
socre of Self-Rating Anxiety Scale
时间窗: one year
result of socre of Self-Rating Anxiety Scale
the success rate of Percutaneous Coronary Intervention
时间窗: one year
the success rate of Percutaneous Coronary Intervention
socre of EuroQol five dimensions questionnaire
时间窗: one year
result of EuroQol five dimensions questionnaire
次要结局
- rate of recurrent myocardial infarction rate(one year)
- rate of cardiac death rate(one year)
- rate of target vessel revascularization rate(one year)