跳至主要内容
临床试验/CTRI/2024/03/063750
CTRI/2024/03/063750尚未招募不适用

Predictive value of strain echocardiography in the diagnosis and outcome of restrictive cardiomyopathy in comparison with technetium -99m-pyrophosphate scintigraphy

Manipal University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
试验地点
1
主要终点
Global longitudinal Strain left ventricle(%)

研究概览

简要总结

After IEC clearance and CTRI registration, this Interventional single arm study will be conducted. Patients with diagnosed RCM at Kasturba hospital, Manipal will be enrolled in this pilot study. Cases are selected if willing to give informed consent. Brief details of the patient’s demographic and clinical history are obtained. This includes age, gender, weight, height and comorbidity history like Hypertension and Diabetes.12 lead ECG will be recorded. ECG gated conventional echocardiography along with strain echocardiography (layer specific strain) will be performed and recorded.  Strain echocardiographic analysis will be performed offline with the already available recorded echo images and will be stored for future references ,where LVEF, RV parameters, strain and strain rate will measured at baseline. Standard views will be taken with patient lying in left lateral decubitus position. Standard views like parasternal long axis and short axis at three levels of LV and apical 4,5 ,3 and 2 chamber views were recorded and stored. LVEF measurements will be taken by M mode and Simpson’s method. These images will be stored for offline analysis of strain. These patients will be later taken for single photon emission computed tomography gamma camera (SPECT-CT) where each subject will be intravenously injected with 740 MBq 99m -technetium -pyrophosphate radiotracer, post one hour after injection a planar scan will be performed and the images will be stored for post processing image reconstruction and data analysis. Strain echocardiographic parameters will be compared with 99m -technetium - pyrophosphate imaging results and assessed to see which among the two is a better predictor for the outcomes (sensitivity and specificity values will be calculated).

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age above 18 years Suspected/diagnosed restrictive cardiomyopathy Suspected/Diagnosed Amyloidosis.

排除标准

  • Breast feeding mothers Previously documented hypersensitivity reaction History of MI History of life threatening arrythmias End stage heart failure LV dysfunction with serious LVOTO Severe hypertension Recent PTE , DVT , active endocarditis , myocarditis or pericarditis LBBB Hypotension Bradycardia.

结局指标

主要结局

Global longitudinal Strain left ventricle(%)

时间窗: Taken once at baseline,no follow up

RV free wall strain(%)

时间窗: Taken once at baseline,no follow up

LA strain(%)

时间窗: Taken once at baseline,no follow up

次要结局

  • Area length Ejection fraction(Tricuspid Annular Plane Systolic Excursion)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vidya Nayak

Manipal College Of Health Professions

研究点 (1)

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