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临床试验/NCT04344353
NCT04344353已完成不适用

Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis

Instituto Nacional de Cardiologia Ignacio Chavez1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The quantifiable assessment and comparison of aortic valve calcium.

研究概览

简要总结

This study evaluates and compares aortic calcium by computed tomography and histopathology in patients with aortic stenosis.

详细描述

  1. Title

Analysis and comparative evaluation of aortic calcium by computed tomography and histopathology in patients with aortic stenosis. 2. Background.

Calcified aortic valve disease (CAVD) was initially considered to be a passive degeneration of the extracellular matrix (EM). Recent studies have shown that within the development of the damage mechanism there is complexity and it is an active (1) and degenerative process where genetic, environmental and epigenetic phases overlap and interact leading to hemodynamic changes in blood flow, endothelial dysfunction and metabolic disorders that lead to low-density lipoprotein cholesterol deposits in the ME where at the same time there is an underlying infiltration of macrophages, oxidative stress, and release of pro-inflammatory cytokines. (2) However, although there are several theories of damage, and some of them are attributed to a diversity of origin such as genetic, congenital, infectious, and degenerative. Finally, the dynamic and functional impact of the heart affects equally. It leads to organic deterioration when the AD reaches clinical and echocardiographic criteria of severity, and the only therapeutic option is the change or replacement of the aortic valve.

The participation of imaging methods such as computerized tomography about to the concerning the aortic valve through the measurement of the aortic calcium score (AVC-CT) as a method to determine the severity of aortic stenosis (AS) in those cases where echocardiographic measurements are conflicting, allows us to see the interest in defining this problem through different angles of investigation (7). In AD, progressive calcification is the trigger factor that also predominantly leads to aortic valve obstruction. (3) Currently, such calcification can be easily quantified using the same acquisition protocol and Agatston Scoring Method as used for a coronary artery calcium scan and is particularly attractive because it provides an assessment of the severity of AD, which is independent of the geometry and ventricular ejection fraction. Advances in the field of CT CVA measurement have been demonstrated in the last decade and are closely associated with hemodynamic measurements of moderate to severe AD in Doppler echocardiography, however, until recently, significant over-positioning of calcium from the aortic valve area among patients with hemodynamically severe AD and those with non-severe AD made it challenging to implement in clinical practice.

This development has generated significant interest in the use of CT-CVA as an alternative and complementary assessment of the severity of AD, especially in patients with discordant echocardiographic findings. (11) In fact: 1) CVA is strongly but non-linearly associated with hemodynamic measures of severity in moderate to severe AD (12). Thus, the determination of CVA may help discriminate severe AD from non-severe AD in patients with discordant findings measured by echocardiography, and 3) in patients with moderate to severe AD, CVA is also likely associated with faster progression of AD and with survival. However, it should be mentioned that the analysis of that series did not make adjustments to the calcium measured in the patients' coronary artery. Although the CVA score has been recommended in the European Society of Cardiology Guidelines to confirm the severity of AD in the following conditions 1) patients with low left ventricular ejection fraction (LVEF), gradient and low flow, in which dobutamine stress echocardiography is inconclusive and 2) patients with low gradient AD and preserved LVEF, and this is not yet part of the American Heart Association (AHA) and American College of Cardiology (ACC) guidelines (13).

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are candidates for aortic valve replacement.
  • Age greater than or equal to 18 years of age.
  • Both genders.
  • With any associated comorbidity
  • Any etiology
  • Hospitalized and with an echocardiographic study showing the variables to be studied
  • Informed Consent.

排除标准

  • Patients who have previously undergone other aortic valve surgery
  • Patients who have received contrast medium ≤24 hours.
  • Patients on hemodialysis.
  • Patients with infection.
  • Patients with cancer.
  • Patients with autoimmune diseases.
  • Pregnant women.
  • Patients who refuse to be included.

结局指标

主要结局

The quantifiable assessment and comparison of aortic valve calcium.

时间窗: 2 days

The study of the valve, which is requested before surgery, will be analyzed in a tomography scan. The study will be performed with a multidetector with a double energy source of 256 cuts definition Flash Medical Systems Forcheim Germany (128 x 2). The images were processed on a workstation (SmartScore by Syngo via, Waukeesha WI Electronics for Medicine). The results were expressed in Agatston units. The study was carried out without a contrast medium and with a radiation equivalent to 1.0 mSv. Employing the sample of the valve tissue obtained from the surgery, a 5-micron segment of the aortic valve, was washed in 0.9% NaCl for 30 seconds immediately after the tissues were fixed by immersion in phosphate buffer with 10% formalin (pH 7.4) for 24 hours. The histopathological sample will be assessed by the head of the pathology department, which will result in the percentage of calcium observed.

次要结局

  • The quantifiable assessmen and comparisont of valve calcium with photomicrographs.(7 days)

研究者

发起方
Instituto Nacional de Cardiologia Ignacio Chavez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Elena Soto, MsC and PhD

Deputy of the Immunology Department.

Instituto Nacional de Cardiologia Ignacio Chavez

研究点 (1)

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