跳至主要内容
临床试验/NCT02749045
NCT02749045终止不适用

The Simultaneous Assessment of Invasive Fractional Flow Reserve and SPECT Myocardial Ischemia Using Regadenoson in the Catheterization Laboratory

Prem Soman2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
27
试验地点
2
主要终点
Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR)

研究概览

简要总结

The overall purpose of this research study is to identify the disparity in ischemia measurement between fractional flow reserve (FFR) used in the cardiac catheterization laboratory and myocardial perfusion stress- single-photon emission computed tomography (SPECT). This study aims to determine the correlation between simultaneous FFR and SPECT obtained using regadenoson in the catheterization laboratory.

详细描述

Patients who are previously scheduled for diagnostic coronary angiography will be approached for consent to be part of the study. If the patient is found to have one or two vessel disease and it is planned by the interventional cardiologist that FFR will be used, then the previously consented patient will be deemed appropriate for the study. The standard procedure will be followed for FFR testing using regadenoson. The patient will then receive the standard dose of Tc-99m sestamibi. The interventional cardiologist will proceed with percutaneous coronary intervention (PCI) if appropriate. Patients will proceed to the cardiac catheterization laboratory holding area post procedure. Patients will then be scheduled to be taken to the nuclear cardiology laboratory one to three hours following the coronary angiogram for standard SPECT acquisition. Patients will be monitored for 2-6 hours or overnight as clinically indicated following diagnostic coronary angiography and PCI. Low dose resting myocardial perfusion scanning may be performed the next day if stress myocardial perfusion study was abnormal.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing clinically-indicated FFR measurement (to determine the hemodynamic significance of intermediate degrees of stenosis) for single or two -vessel epicardial coronary disease during diagnostic coronary angiography for suspected coronary artery disease.

排除标准

  • Patients with 3-vessel disease
  • Prior coronary artery bypass grafting
  • Patients with second or third- degree atrioventricular block, without a functioning pacemaker
  • Patients who have ingested caffeine-containing products within the past 12 hours.

结局指标

主要结局

Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR)

时间窗: 24 hours

The concordance will be calculated as the percentage of patients who had an abnormal FFR (\<0.8) and an abnormal SPECT (a perfusion defect on the SPECT) PLUS patients who had a normal FFR (≥ 0.8) and a normal SPECT. concordance= patients with abnormal FFR and abnormal SPECT + patients with normal FFR and normal SPECT/ total no. of patients

次要结局

未报告次要终点

研究者

发起方
Prem Soman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prem Soman

Associate Professor of Medicine

University of Pittsburgh

研究点 (2)

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