The HEART BREAK Study: Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 主要终点
- Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging
研究概览
简要总结
Purpose
- To investigate the effects of cardiac imaging radiation on the induction of DNA double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked hair follicle cells.
- To estimate whether the use of breast shields in cardiac computed tomographic angiography (CCTA) limits the effective radiation exposure of breast tissue.
详细描述
The primary objective of the study is to analyze blood and hair samples from patients undergoing cardiac imaging to estimate radiation exposure levels as well as their biological effects (i.e. to determine the degree of genotoxicity by measuring the amounts of DNA double-strand breaks).
The secondary objective is to investigate whether the use of in-plane breast shielding in female patients undergoing CT angiography (CCTA) limits the radiation exposure of breast tissue and subsequent DNA damage in blood lymphocytes and hair follicle cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female adult subjects (age greater than 18 years)
- •Referred for cardiac computed tomography angiography (CCTA), myocardial perfusion scintigraphy (MPS), or diagnostic invasive coronary angiography (ICA).
排除标准
- •Female patients that identify themselves as pregnant or have a positive pregnancy test prior to cardiac imaging.
- •History (present or past) of leukemia or lymphoma.
- •History of radiation therapy
- •X-ray examination or scintigraphy within the last 72 hours.
- •History of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
- •Patients undergoing percutaneous coronary intervention at completion of diagnostic left heart catheterization
结局指标
主要结局
Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging
时间窗: Change from baseline double strand DNA breaks at 30 minutes post-imaging
The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA. In addition, changes in DNA double-strand breaks from baseline following cardiac testing in the observational arm is being assessed in an observational manner.
次要结局
未报告次要终点
研究者
Todd C. Villines
Director of Cardiovascular Research
Walter Reed National Military Medical Center