跳至主要内容
临床试验/NCT05709652
NCT05709652招募中不适用

Impact of Fast Gantry Rotation Cardiac CT Angiography on Coronary Motion Artifacts in the Absence of β-Blocker Premedication in Patients Undergoing Aortic Stenosis Workup: a Single-centre Randomized Controlled Trial

David C. Rotzinger2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年2月27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
124
试验地点
2
主要终点
Interpretable CTA rate per patient

研究概览

简要总结

This study aims to evaluate the clinical value of a novel CT gantry supporting a .23 second rotation time and systematically compare it with 0.23 second rotation time, in patients with clinically indicated aortic CTA in the workup of aortic stenosis. Patients will be randomly assigned .23 or .28 sec rotation time CTA. Coronary artery interpretability rates will be determined in both groups.

详细描述

Coronary artery analysis is an essential component of cardiac CT, but is often challenging without beta-blocker use. CT's technological advances are continuously evolving, paving the way for safer and more accurate diagnoses. Part of these innovations is the development of faster rotation speeds (0.23 sec/rotation), which is expected to allow for heart rate-independent CCTA.

Patients subjected to aortic stenosis workup routinely undergo invasive coronary angiography (ICA) in the catheterization laboratory, voiding the need to control the heart rate at the time of cardiac CT because aortic valve measurements can be performed even at higher heart rate. Still, cardiac CT in this context is performed with ECG-gating, and attempting to evaluate coronary arteries is possible without interfering with clinical decisions. Also, the existing literature advocates the use of gantry rotation speeds of at least 0.5 sec/rotation; consequently, the use of 0.28 versus 0.23 sec/rotation for this study will comply with current guidelines and will have no detrimental impact on patient management. This study aims to evaluate coronary artery interpretability in patients subjected to cardiac CT for the anatomical assessment of aortic valve stenosis prior to endovascular (transcatheter aortic valve implantation [TAVI]) or surgical therapy.

Patients will be enrolled after providing written, informed consent, and will be randomly assigned either to the test (0.23 sec rotation time) or control group (0.28 sec rotation).

The participants concerned are not subjected to any additional invasive or stressful procedure compared with those undergoing aortic stenosis workup in clinical routine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Subjected to cardiac CT due to known or suspected aortic valve stenosis

排除标准

  • Patients unable to hold their breath, deaf or visually impaired
  • Estimated glomerular filtration rate (eGFR) of <30 mL/min
  • Hemodynamic instability or cardiogenic shock, Acute pulmonary edema, Exacerbated chronic obstructive pulmonary disease, Pregnant and breast-feeding women
  • Patients with prior coronary artery bypass grafting (CABG)
  • Patient incapable of discernment

结局指标

主要结局

Interpretable CTA rate per patient

时间窗: Up to 90 days

Number of patients with diagnostic image quality for coronary artery disease

次要结局

  • CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard(Coronary angiography performed withing 30 days of CTA)
  • Quantitative image quality (contrast to noise ratio)(Up to 90 days)
  • Radiation dose per patient(Up to 90 days)
  • Relationship between heart rate and non-diagnostic CTA(Up to 90 days)
  • Interpretable CTA rate, per segment(Up to 90 days)

研究者

发起方
David C. Rotzinger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David C. Rotzinger

MD, PhD, head of cardiovascular and thoracic radiology

University of Lausanne Hospitals

研究点 (2)

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