DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- QFR- iFR diagnostic grey zone calculation.
研究概览
简要总结
A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.
详细描述
During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment.
Fractional Flow Reserve (FFR) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. The instantaneous wave-free ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. Large randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of outcome.
Quantitative Flow Ratio (QFR) is another new method for evaluating the functional significance of coronary stenosis It is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. The diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is enrolling for confirmation.
A stepwise approach of QFR and iFR could make the functional assessment of intermediate stenoses more practical and cost-effective. However before being used as a combination in daily practice, QFR has to be validated in respect to iFR.
The primary objective of the trial is to investigate the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
- •Patients witch semi recent (>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
- •Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- •Eligible for coronary angiography and/or percutaneous coronary intervention
- •Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
- •Exclusion criteria:
- •Contraindication to adenosine administration
- •Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
排除标准
- 未提供
结局指标
主要结局
QFR- iFR diagnostic grey zone calculation.
时间窗: 1 hour
QFR limits for achieving 95% sensitivity and specificity in comparison to iFR
Diagnostic performance of QFR in comparison to iFR
时间窗: 1 hour
reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR
次要结局
- Diagnostic performance of QFR in comparison to FFR(1 hour)
- Diagnostic performance of iFR in comparison to FFR(1 hour)
- iFR- FFR diagnostic grey zone calculation.(1 hour)
- Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.(1 hour)
- QFR- FFR diagnostic grey zone calculation.(1 hour)
- effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.(1 hour)
- Effect of lesion location on QFR-iFR-FFR disagreement.(1 hour)
研究者
Christoph Jensen, MD Associate Prof.
Christoph Jensen, MD, Associate Professor of medicine
Contilia Clinical Research Institute