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临床试验/CTRI/2024/05/067897
CTRI/2024/05/067897尚未招募不适用

Multi-modal characterization of endomyocardial biopsyspecimen for predicting myocardial fibrosis and heart failure

Sri Jayadeva institute of Cardiovascular Sciences and research2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Extent of myocardial fibrosis and altered heart tissue physical

研究概览

简要总结

During a cardiovascular disorder, remodeling of heart tissues

occurs. If this remodeling is permanent, it can cause organ

malfunction and even death, if left untreated. Therefore, if the

state of the heart tissues is analyzed at an early stage of the

disease, it can be lifesaving. Right ventricular dysfunction

(RVD) is known to have prognostic significance for several

cardiovascular conditions such as rheumatic heart disease,

myocardial infarction, and heart failure.

Therefore, the physiological changes of ventricular

myocardium can be characterized to predict cardiovascular

conditions which can be life-threatening to the patients. Due to

the unique morphological and physiological properties of the

ventricular myocardium and the clinical significance of

ventricular failure, there is a need to explore specific

mechanisms of myocardial fibrosis and interstitial remodeling

using various characterization methods.

We have already developed a portable diagnostic tool for

characterizing biopsy tissues based on its electrical, optical,

acoustic, and mechanical properties for other parts of the

body.

As a pilot study, we have already explored the electrical and

optical properties of ventricular myocardial tissues obtained

from endomyocardial biopsy specimens from patients

suffering/who suffered from myocardial fibrosis (for diseased

tissue samples) and cadavers (for healthy myocardium

samples), using NIR-based linear polarization system and,

electrical impedance measurement with fabricated microchip.

Our preliminary results using these modalities are

encouraging.

Hence, we would like to explore the mechanics of fibrosis of

heart tissues for predicting cardiovascular condition. This

helps us to develop an intraoperative minimally invasive probe

for characterizing the heart tissues in-vivo.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with heart failure and myocardial fibrosis who consent to contribute endomyocardial biopsy specimen during cardiac surgery at Sri Jayadeva Institute of Cardiovascular Sciences and Research.
  • Exclusion criteria details: Multiorgan failure.

排除标准

  • Patients with valvular disease not undergoing cardiac surgery.

结局指标

主要结局

Extent of myocardial fibrosis and altered heart tissue physical

时间窗: At time of tissue characterization at end of study of 3 years

characteristics.

时间窗: At time of tissue characterization at end of study of 3 years

次要结局

  • Clinical outcome related to degree of fibrosis and physical characteristics of tissue(3 years)

研究者

申办方类型
Research institution and hospital

研究点 (2)

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