Invasive funCtional assEssment Using Diastolic HypEremia-Free RATio in Patient With Coronary Artery Disease: a Prospective Observation Study (ICE-HEAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Comparison of pre-interventional value between DFR <=0.89 and FFR <=0.80
研究概览
简要总结
The investigators aimed to identify the value of concordance between the diastolic hyperemia-free ratio (DFR) and fractional flow reserve (FFR) during pre-interventional and post-interventional period using a 0.014" COMET II Pressure Guidewire
详细描述
The physiologic assessment of coronary artery disease and ischemia-guided percutaneous coronary intervention (PCI) has become a standard practice for patients with coronary artery disease. Fractional flow reserve (FFR) represents hyperemic flow limitation caused by an epicardial coronary stenosis and its clinical usefulness has been proven by many clinical studies. However, the FFR is limited to clinical use despite the fact that it is recommended by the guideline due to the inconvenience of patients using medications used to induce maximum hyperemia, and the need for additional procedure time. Recently, a physiologic index which does not require hyperemia, instantaneous wave free ratio (iFR), was introduced and recent trials showed non-inferiority of iFR-guided strategy for 1-year clinical outcome, compared with FFR-guided strategy. Recently, not only iFR but also various intravascular pressure measurement techniques have been developed, one of which is diastolic hyperemia-free ratio (DFR). DFR uses the mean Pd/Pa calculated over the period in diastole defined as that during which arterial pressure is negatively sloped and below the mean arterial pressure. DFR showed equivalence as compared to gold standard FFR in the discrimination of non-culprit lesions requiring revascularization in patients with NSTEMI. In the case of DFR, there is no issue in terms of safety because it is conducted in the same way as iFR, but there are not many studies on the validation between DFR and FFR. Therefore, the present study aimed to identify the quality of concordance between DFR and FFR, determine the features associated with discrepancies in DFR and FFR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, ≥ 19 years of age, who are diagnosed with stable angina pectoris including silent ischemic heart disease and 50~90% stenosis of the coronary artery.
- •Acute coronary syndrome patients with multivessel disease who have 50~90% stenosis of a non-culprit vessel on coronary angiography.
排除标准
- •Patients with acute coronary syndrome and single vessel disease.
- •Patients with hypersensitivity or contraindication to antiplatelet treatment.
- •Female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
- •Patients with a life expectancy shorter than 1 year.
结局指标
主要结局
Comparison of pre-interventional value between DFR <=0.89 and FFR <=0.80
时间窗: through study completion, an average of 1 year
Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions with a cut-off point to defer the treatment of FFR\< = 0.80 (with intravenous sigmart) and DFR \< = 0.89.
次要结局
- Comparison of the value between DFR <=0.89 and Pd/Pa <=0.92(through study completion, an average of 1 year)
- Discordance factors between DFR >=0.89 and FFR >=0.80(through study completion, an average of 1 year)
- Mortality within 30 days(through study completion, an average of 1 year)
- Comparison of post-interventional value between DFR >=0.89 and FFR >=0.80 when DFR/FFR-guided PCI is performed.(through study completion, an average of 1 year)
- Comparison of the delta value (Δ post-interventional - pre-interventional value) between DFR and FFR.(through study completion, an average of 1 year)
研究者
Yongcheol Kim
Clinical Associate Professor
Yonsei University