Left Ventricular Strain Assessment Using 3d Cardiac Magnetic Resonance Technique In Asymptomatic Pediatric Patients Who Received Cardiotoxic Chemotherapy
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
- 否
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
Majd Makhoul
Sponsor/Investigator
University of Kentucky
