NCT00165425进行中（未招募）不适用
Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- To determine the feasibility of a cardiac screening program in patients who are 5 to 10 years our from initial mediastinal irradiation for Hodgkin's disease.
研究概览
简要总结
The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease. In this study, we would also like to screen for cardiac risk factors that can be modified either through life-style changes or medications, to uncover significant abnormal heart findings in which treatments may be needed, and to see if there is a link between cardiac health and quality of life.
详细描述
- On the day of the patient's scheduled follow-up visit with their oncologist, additional blood work will be obtained and the patient will fill out questionnaires concerning their general health and assessing quality of life.
- A separate cardiology visit with a preventative cardiologist will be performed. At this visit, the patient will undergo a Stress Echocardiogram.
- A Stress Echocardiogram is made up of three parts: Resting echo study, stress test and repeat echo while the heart is still beating fast.
- A resting echo provides the baseline examination and demonstrates the size and function of various chambers of the heart.
- The stress test involves exercise using a treadmill or a stationary bike. In patients who are unable to complete a high level of exercise due to physical limitations, stress to the heart is provided by a pharmaceutical or chemical stimulation to the heart. Exercise is started at a slower, warm-up speed and then increased every 3 minutes. Exercise is abruptly stopped once the patient exceeds 85% of the target rate. EKG recordings are made every minute of exercise and then again after exercise is stopped. Blood pressure is recorded at three minute intervals during exercise and then again at rest.
- Immediately after exercise is stopped, the patient will undergo a repeat echocardiogram.
- If no cardiac abnormalities are detected, the screening tests will be repeated every 3 years, if the patient is less than 10 years out from their initial treatment. If the patient is more than 10 years from initial treatment, then the tests will be repeated at approximately 18 months from the initial screening and once more at the end of the third year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated at Brigham and Women's Hospital or Dana-Farber Cancer Institute for Hodgkin's disease with mediastinal irradiation
- •Age > or = to 15 years of age
- •Five years or longer after initial treatment
- •Relapse-free interval of > 1 year
- •Exclusion criteria:
- •Patients treated for Hodgkin's disease outside of Brigham and Women's Hospital or Dana-Farber Cancer Institute
- •Current age < 15 years of age
- •Less than 5 years out from initial treatment
- •Relapses within 1 year
排除标准
- 未提供
结局指标
主要结局
To determine the feasibility of a cardiac screening program in patients who are 5 to 10 years our from initial mediastinal irradiation for Hodgkin's disease.
时间窗: 3 years
Compliance of screening and follow up visits are tracked
次要结局
- to correlate cardiac structural abnormalities with level of fatigue.(3 years)
- To prospectively collect data on the prevalence of modifiable cardiac risk factors and the spectrum of cardiac structural abnormalities in this patient populations(3 years)
- to correlate cardiac structural abnormalities with quality of life(3 years)
研究者
Andrea K. Ng, MD
Professor of Radiation Oncology
Dana-Farber Cancer Institute
研究点 (4)
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