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