跳至主要内容
临床试验/NCT07331116
NCT07331116已完成不适用

Correlations Between Biopsy Verified Myocardial Fibrosis and Echocardiography Parameters in Patients With Severe Aortic Stenosis

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年4月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Echocardiography parameters of systolic and diastolic function

研究概览

简要总结

Patients with aortic stenosis waiting for aortic valve repair were investigated with echocardiography preoperatively, and a myocardial biospy was taken during the operation. The investigators aim to perform a retrospective analysis of these data, to look for correlations between biopsy-verified myocardial fibrosis and echocardiography parameters.

The patients also had cardiac magnetic resonance imaging performed, for a non-invasive quantification of myocardial fibrosis.

详细描述

The primary purpose of the study is to retrospectively compare echocardiography measurements with a myocardial biopsy taken perioperatively in patients with aortic stenosis requiring aortic valve replacement.

Echocardiography and endomyocardial biopsy have been performed in close proximity in time. Due to a small sample size and a large number of echocardiography measurements being possible, only a limited number of prespecified comparisons are performed.

Cardiac magnetic resonance (CMR) was also performed in patients without contraindication, providing a non-invasive gold standard for diffuse fibrosis and replacement fibrosis. A secondary goal will be to investigate how echocardiography parameters performs compared to CMR in quantifying myocardial fibrosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Planned for aortic valve replacement for symptomatic, severe aortic stenosis

排除标准

  • Previous myocardial infarction / coronary disease that can cause fibrosis
  • Do not wish to participate in study

研究组 & 干预措施

Aortic stenosis without biopsy-verified myocardial fibrosis

Periopererative echocardiography

干预措施: Transthoracic echocardiography (Diagnostic Test)

Aortic stenosis with biopsy-verified myocardial fibrosis

Periopererative echocardiography

干预措施: Transthoracic echocardiography (Diagnostic Test)

Aortic stenosis with biopsy-verified myocardial fibrosis

Periopererative echocardiography

干预措施: Cardiac magnetic resonance imaging (Diagnostic Test)

Aortic stenosis without biopsy-verified myocardial fibrosis

Periopererative echocardiography

干预措施: Cardiac magnetic resonance imaging (Diagnostic Test)

结局指标

主要结局

Echocardiography parameters of systolic and diastolic function

时间窗: Time between echocardiography exam and endomyocardial biopsy was kept as short as possible, and not more than one month apart. If no cardiac event had happened in between, echocardiography and biopsy could be regarded as being taken at the same time.

Echocardiograhic parameters on structure and function of the heart, as described in guidelines for echocardiography assessment: Basal hypertrophy of interventricular septum, in mm. LV end diastolic mass (preferably from 3D volume of LV) LV end diastolic mass, indexed (preferably from 3D volume of LV) Left ventricular global longitudinal strain (%) Left ventricular ejection fraction, 3D Left ventricular septal strain rate, peak systolic, sample placed in basal septum Grading of diastolic dysfunction (ref EACVI/ASE guidelines) Left atrial strain, reservoir function, biplane Left atrial strain, conduit function , biplane Left atrial strain, (atrial) contraction phase, biplane Severity of aortic stenosis, evaluated by echocardiography (mild, moderate, severe)

Echocardiography parameters of systolic and diastolic function

时间窗: The time between echocardiography exam and endomyocardial biopsy was kept as short as possible, and not more than one month apart. If no cardiac event had happened in between, we could now regard echocardiography and biopsy being taken at the same time.

Echocardiograhic parameters on structure and function of the heart, as described in guidelines for echocardiography assessment: Basal hypertrophy of interventricular septum, in mm. LV end diastolic mass (preferably from 3D volume of LV) LV end diastolic mass, indexed (preferably from 3D volume of LV) Left ventricular global longitudinal strain (%) Left ventricular ejection fraction, 3D Left ventricular septal strain rate, peak systolic, sample placed in basal septum Grading of diastolic dysfunction (ref EACVI/ASE guidelines) Left atrial strain, reservoir function, biplane Left atrial strain, conduit function , biplane Left atrial strain, (atrial) contraction phase, biplane Severity of aortic stenosis, evaluated by echocardiography (mild, moderate, severe)

次要结局

  • CMR parameters of systolic and diastolic function(CMR was taken preoperatively, and at 1-year postoperative check-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验