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临床试验/NCT02146768
NCT02146768已完成不适用

A Novel Low-dose-contrast Cardiac Computed Tomography Method for Pre-Procedural Guidance in Transcatheter Aortic Valve Replacement

Baylor Research Institute2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
2
主要终点
Number of patients with acute renal failure.

研究概览

简要总结

Low-dose-contrast CCTA can effectively and safely assess the aortic valve apparatus, and effectively direct the trans-catheter heart valve (THV) size selection by providing accurate annulus sizing, and provide adequate pre-procedural risk-stratification guidance for TAVR/TAVI.

详细描述

A. INTENT AND PURPOSE

Background:

Optimizing procedural and patient outcomes relies heavily on tomographic imaging data guidance for patients being evaluated for trans-catheter aortic valve replacement or implantation (TAVR) by providing accurate information of the aortic valve apparatus (aortic annulus and its pertinent neighboring structures).

The aortic valve annulus is a dynamic complex elliptical or ovoid 3D entity that is also subject to constant shape deformation across the cardiac cycle in addition to being influenced by the thoracic and intra-thoracic anatomy or variations. Given this inherent nature of the aortic valve annulus, electrocardiographic gated cardiac computed tomographic angiography (CCTA), a robust dynamic 3-dimensional imaging modality, is now widely accepted as the "gold-standard" for evaluating the aortic valve apparatus (AVA). To maximize the information obtained by CT, imaging needs to be performed with intravenous contrast injection.2 CCTA requires administration of iodinated contrast. The volume of iodinated contrast medium is of concern in many patients because candidates for TAVR frequently have impaired renal function.2 Contrast reduction and adherence to protocols for prevention of contrast-induced nephropathy is recommended.2 For access planning via the ilio-femoral route, some groups have reported direct aortic injection with extremely low volumes of contrast.

Reduction of contrast volumes for CCTA of the AVA can be achieved by using lower flow rates than for coronary CT angiography. Although 5 mL/s is typically recommended for coronary imaging, 3 mL/s may sometimes be sufficient for imaging patients in the workup for TAVR.2 Though suggested, these CCTA lower flow rates have not been systematically performed and validated in a population being evaluated for candidacy for TAVR. And as recommended by guidelines, a standard bolus of 80 mL to 120 mL of low-osmolar iodinated contrast is usually necessary for optimal TAVR CCTA scanning.1 In these patients, reducing the dose of iodinated contrast at the time of CCTA acquisition in an attempt to minimize renal injury, and at the same time being able to accurately assess the aortic annulus apparatus (AVA) will be of paramount importance. Some reduction of contrast nephropathy can be accomplished by minimizing contrast volume and the use of iso-osmolar or low-osmolar contrast agents. It has been suggested that the contrast volume threshold can be estimated by using the ratio of contrast volume to creatinine clearance. Nephrotoxicity is more likely when the contrast volume/creatinine clearance ratio exceeds 3.7:1.12 And using this, 3.7 x eGFR (estimated glomerular filtration rate) can be set as the maximal contrast dose for an imaging test or invasive procedure.12 14 CCTA acquisition methods Images were acquired with a Brilliance 64-slice CT scanner (Philips Healthcare, Andover, Massachusetts, USA). As per the recommendations on radiation protection in cardiovascular CT by the Society of Cardiovascular Computed Tomography (SCCT), a tube potential of 100 kV will be considered for patients weighing <90 kg or with a body mass index (BMI) <30; whereas a tube potential of 120 kV will be considered for patients weighing >90 kg and with a BMI >30. It will be adjusted, based on each individual patient's size, to the lowest setting that guarantees acceptable image noise for a suitable signal-to-noise ratio (SNR) to perform analysis.15 The patients' eGFR was first calculated using the MDRD (modification of disease in renal diet) GFR formula. The maximal allowable contrast dose for the CCTA was calculated using 3.7 x [(patient's BSA/1.73) x MDRD-eGFR].14 Next, the dose of contrast chosen for the CCTA was < 50% of the maximal allowable contrast dose. The MDRD formula can underestimate the GFR by about 6.2% in patients with chronic kidney disease and by about 29% in healthy individuals, making this an extremely suitable conservative approach for calculating the contrast dosing, with a tendency only to underdose and never to overdose the contrast. With our extensive experience in doing this, we have decreased the total contrast dose for CCTA of the AVA to 45 ml with satisfactory image quality and SNR for post-processing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • > 18 years of age (75 patients who received low-dose contrast matched by body mass index with 75 patients who received traditional dose contrast) seen at THHBP between January 1, 2011 and June 30, 2013

排除标准

  • Patients with MDRD eGFR < 25 will be excluded

结局指标

主要结局

Number of patients with acute renal failure.

时间窗: Baseline (pre and post procedure)

Compare quality and safety of traditional-dose-contrast CCTA versus low-dose-contrast from a renal standpoint, by using serum creatinine and MDRD - eGFR.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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