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临床试验/NCT02130934
NCT02130934撤回不适用

Left Ventricular Strain Assessment Using 3d Cardiac Magnetic Resonance Technique In Asymptomatic Pediatric Patients Who Received Cardiotoxic Chemotherapy

Majd Makhoul2 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Ventricular Function Measurement

研究概览

简要总结

This is a non-randomized prospective pilot study in a single academic center with historic controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who have undergone childhood cancer treatment that has cardio-toxic effects to historic controls. The ultimate goal of this study is to develop a safe and effective method for early diagnosis of heart problems in children who are receiving chemotherapy treatments that may be toxic to the heart.

详细描述

The following tests and procedures will be performed after consent has been obtained. All tests and procedures noted below are being done for the sole purpose of the study:

Visit 1. Subjects will be asked to complete some questionnaires and answer questions regarding smoking status and use of alcohol or smokeless tobacco. We will also gather basic information such as age, height, weight, gender, ethnicity, race, pertinent medical history as well as collect vital sign information (height, weight, blood pressure, heart and respiratory rate.) Next, subjects will undergo a routine transthoracic echocardiogram.

Visit 2. Following the completion of the echocardiogram, and if selected to take part in the study, subjects will be schedule for a cardiac MRI test within a 3 months period.

When subjects come in for Visit 2, they will receive a 12 lead electrocardiograph (ECG) before the cardiac 3D MRI.

All females who are capable of becoming pregnant, except those who are age 11 and under, will then undergo urine pregnancy testing. If it is found that you are pregnant you will not be allowed to be in the study. If the female is under 18 and a positive pregnancy test result is obtained, we will inform both the participant and her parent/guardian.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
8 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Childhood cancer treatment which has been completed
  • Received anthracyclines as part of childhood cancer treatment, at least 150 mg/m2 as cumulative dose
  • normal left ventricular systolic and diastolic functions on echocardiogram

排除标准

  • Ongoing cancer treatment
  • Pregnancy
  • Inability to undergo a cardiac MRI
  • Abnormal ventricular systolic or diastolic function on echocardiogram

结局指标

主要结局

Ventricular Function Measurement

时间窗: Up to 2 years

Quantify ventricular functional measurements including strain patterns and measurements using offline processing software that Dr. Fornwalt lab has.

次要结局

未报告次要终点

研究者

发起方
Majd Makhoul
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Majd Makhoul

Sponsor/Investigator

University of Kentucky

研究点 (2)

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