跳至主要内容
临床试验/NCT03381014
NCT03381014Unknown不适用

Added Benefit of Speckle Tracking Echo to Molecular Expression of High Sensitive Troponin I and Cardiac Ryanodine Receptor in Early Detection of Cardiomyopathy in Patients Receiving Anthracycline Chemotherapy

Assiut University0 个研究点目标入组 50 人开始时间: 2018年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
50
主要终点
early detection of cardiomyopathy

研究概览

简要总结

Early detection of cardiomyopathy in patients receiving Anthracycline chemotherapy and determine if speckle tracking echo and Troponin gene will add benefit for early detection of cardiomyopathy.

Improve economic impact of oncologic patients from whom high sensitive troponin negative and normal speckle tracking patients can be safely excluded from long-term cardiac monitoring programs.

To correlate between the molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy

详细描述

Anthracycline chemotherapy has saved the lives of many cancer victims during the 50 years after their discovery.These patients are prone to higher risk of cardiovascular death than the risk of tumor recurrence, particularly in childhood cancer survivors in whom the cardiac mortality rate is seven fold higher.

Cardiac toxicity remains an important side effect of anticancer therapies, leading to increased mortality due to mainly heart failure, but also arrhythmias, hypertension, thromboembolism.

The time from early development of cardiac dysfunction to the modification or end of chemotherapy and beginning of heart failure therapy, is an important determinant of the extent of recovery.

The Cardiotoxicity of anthracyclines may be acute, early or late. A recent study involving 2625 patients (mean follow-up 5 years); showed a 9% overall incidence of Cardiotoxicity after anthracycline treatment, 98% of cases occurred within the first year and were asymptomatic.

Cardiotoxicity has been defined using various classifications. Recent guidelines suggest that Cancer therapeutics-related cardiac dysfunction (CTRCD) is defined as a decrease in the LVEF (by echocardiography) of >10 percentage points to a value below the lower limit of normal.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • all Newly diagnosed cancer patients with who will receive Anthracycline based regimen chemotherapy

排除标准

  • Insufficient ultrasound image quality, defined as more than three LV segments being suboptimally visualized by conventional echocardiography.
  • Valvular heart disease
  • Hypertensive heart disease
  • Cardiomyopathy
  • Chronic renal failure
  • Chronic obstructive air way disease (COPD)

结局指标

主要结局

early detection of cardiomyopathy

时间窗: about one year

using speckle tracking echo to early diagnosis of cardiomyopathy

identify patients whose at risk to develop cardiomyopathy

时间窗: about one year

Using the high sensitive troponin with quantitative measurements as biomarker.

次要结局

  • molecular gene expression of troponin genes and ryanodine receptor in cardiomyopathy(same time frame ... about one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Mahmoud Morsy

doctor

Assiut University

相似试验

Early Detection of Cardiomyopathy by Speckle Echo,... | 临床试验