跳至主要内容
临床试验/NCT04882488
NCT04882488招募中不适用

Correlation of FFR and iFR With Cardiac PET Perfusion (at Rest and Under Adenosine) in the Evaluation of Intermediate Coronary Stenoses in Patients With Severe Aortic Valve Stenosis

Heart and Diabetes Center North-Rhine Westfalia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure

研究概览

简要总结

Aortic valve stenosis (AS) affects 2-7% of persons > 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Angina in AS caused by significant reduction of coronary flow reserve (CFR). CFR is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). FFR (fractional flow reserve) use in patients with AS potentially invalid due to dysfunctional CFR leading to potential undertreatment of CAD in these patients.CFR disturbance in AS mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. Current studies are investigating the validity of FFR and iFR in AS patients. Recent data demonstrate very good correlation between FFR and iFR derived values to PET myocardial perfusion imaging values in patients with no evidence of AS. Our study aims to investigate the diagnostic performance of FFR and iFR in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate FFR- and iFR derived values with those extracted from PET-perfusion Imaging.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients with severe aortic Stenosis eligible for transcatheter aortic stenosis
  • •left ventricular ejection fraction > 55%
  • •no intolerance of Adenosin
  • •no history of bradycardia, atrioventricular Blockade
  • •intermediate coronary Stenosis with FFR> 0.8

排除标准

  • •intolerance of Adenosin
  • •left ventricular ejection fraction < 55%

结局指标

主要结局

Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure

时间窗: 3 months

Evaluation of FFR-negative intermediary coronary stenoses in Patients with severe Aortic Stenosis Prior and 3 months following TAVI

次要结局

  • Clinical Evaluation Prior to and following TAVI(3 months)

研究者

发起方
Heart and Diabetes Center North-Rhine Westfalia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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