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临床试验/NCT01431027
NCT01431027已完成不适用

Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年8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
45
试验地点
2
主要终点
To show that torsional hysteresis relates to invasive hemodynamic measure of diastolic function

研究概览

简要总结

Diastolic dysfunction refers to abnormal mechanical properties of the myocardium and includes abnormal LV diastolic distensibility, impaired filling and slow or delayed relaxation- regardless of whether the ejection fraction is normal or depressed and whether the patient is asymptomatic or symptomatic. Epidemiologic studies have demonstrated high prevalence of diastolic heart failure (DHF). The quality of life of these patients is impaired and the clinical outcomes are similar to those with heart failure with systolic dysfunction. Therefore diastolic dysfunction has significant adverse economic impact that is expected to grow further with time. Clinical characteristics alone may not be sufficient to diagnose diastolic dysfunction. A number of invasive and non-invasive parameters have been proposed to diagnose diastolic dysfunction. Most of the presently used non-invasive parameters have a number of limitations. High fidelity measurement of the left ventricular pressures is needed to accurately diagnose diastolic dysfunction. Obtaining it in routine clinical practice is impractical.

In this protocol the investigators have proposed a novel non-invasive parameter called 'Torsional Hysteresis' as a measure of diastolic function. This will be measured using non-invasive cardiac MRI technique. During left ventricular contraction and relaxation, myocardium deforms. During cardiac cycle the myocardium goes back to baseline state prior to beginning of each contraction. However the rate with which it returns to the baseline state is variable. Torsion indicates relative wringing motion of the ventricle around a left ventricular axis and is a global parameter of left ventricular deformation. The parameters have defined a new parameter called torsional hysteresis based on non invasive cardiac MRI assessment. The parameters have hypothesized that for diastolic dysfunction, the torsional hysteresis area is increased as compared to no diastolic dysfunction group.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Major inclusion criteria: Normal screening LV ejection fraction.

排除标准

  • Atrial fibrillation or other significant cardiac arrhythmia on ECG
  • Presence of pacemaker or defibrillator
  • Angioplasty or primary coronary intervention PCI/PTCA during index cardiac catheterization.
  • Patient is unable to undergo cardiac MRI due to contraindication to MRI (MRI incompatible metal prosthesis or implants or significant claustrophobia).
  • Patient taking phosphodiesterase 5 inhibitor (eg. sildenafil) will be excluded due to potential interaction with nitroglycerin.

结局指标

主要结局

To show that torsional hysteresis relates to invasive hemodynamic measure of diastolic function

时间窗: one time at enrollment

To show that torsional hysteresis relates to invasive hemodynamic measure of diastolic function: a) Exponential fall of pressure during isovolumic relaxation phase by the time constant of relaxation, tau and b) LV end diastolic pressure-volume relationship (EDPVR).

次要结局

  • To demonstrate that torsional hysteresis is a relatively load independent measure of global diastolic function(one time at enrollment)
  • To evaluate the sensitivity and specificity of torsional hysteresis in diagnosing diastolic dysfunction(one time at enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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