Radiation Exposure in Diagnostic Angiography With and Without a New Low Dose Exposure Protocol -Radiation Exposure Reduction Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the difference in the radiation exposure levels received by patients undergoing diagnostic angiography with and without the new low dose exposure protocol
研究概览
简要总结
- The patients suspected coronary artery disease or those needing an angiography as per the inclusion criteria would be included after a 2d echocardiography and treadmill test/ stress myocardial stress imaging (if indicated) after a written and informed consent.
- Anthropometric and lab paraments would be recorded.
- Study will have 2 arms. I. A study arm 1 - baseline comparative arm of patients having already undergone angiography and fitting the inclusion criteria. The radiation exposure of this group would be collected from database of already done studies in the months prior to the initiation of the study (so as to prevent observer bias which may happen once the interventional cardiologist knows his inclusion in study, and may use a shorter or longer cine runs, thus influencing the outcomes). This would best represent the real-world data set, according to the routinely followed standard dose/ older low dose protocol.
II. A study arm 2 - a comparative arm where the patients being once eligible for the study; would undergo angiography using the new low dose protocol. 4. Post completion of the sample size the data of each angiographic view would be noted in both the study arms
详细描述
INTRODUCTION
The increasing prevalence of cardiovascular diseases has led to a surge in the use of diagnostic angiography procedures. While these procedures are crucial for diagnosing and treating heart conditions, they also involve significant exposure to ionizing radiation. Excessive radiation exposure can pose serious health risks, including an increased risk of cancer and other adverse effects.
The RADRED study aims to address the critical issue of radiation exposure in cardiology catheterization labs. By comparing the radiation dose received by patients undergoing diagnostic angiography with and without a new low dose exposure protocol, the study seeks to evaluate the effectiveness of this protocol in reducing radiation exposure.
Several factors contribute to the need for such research. Firstly, the growing number of patients undergoing diagnostic angiography, particularly elderly individuals and those with multiple comorbidities, increases the cumulative radiation exposure to the population. Secondly, advancements in imaging technology have led to more complex procedures, often requiring longer fluoroscopy times, which can result in higher radiation doses. Finally, there is a growing awareness of the potential long-term health consequences of radiation exposure, particularly for vulnerable populations.
The RADRED study has the potential to make a significant contribution to the field of cardiology by demonstrating the feasibility and benefits of implementing a low dose exposure protocol in catheterization labs. By reducing radiation exposure, this protocol can help to protect the health of patients and healthcare providers, while also improving the overall efficiency and cost-effectiveness of diagnostic angiography procedures AIM To study determine the difference in the radiation exposure in diagnostic angiography with and without a new low dose exposure protocol
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 patients who qualify for a need of diagnostic angiography and are finally found to have normal epicardial coronaries, e.g.:
- •Pre aortic or mitral valve replacement angiography
- •TMT positive for inducible ischemia
- •SPECT MPI positive patients
- •Cradiologically symptomatic patients with ECG abnormalities, who cannot be subjected to stress test
- •High risk pre transplant patients
排除标准
- •Those who are unwilling for study
- •Patients who come with STEMI or NSTEMI
结局指标
主要结局
To determine the difference in the radiation exposure levels received by patients undergoing diagnostic angiography with and without the new low dose exposure protocol
时间窗: Through study completion, and average of 06 monhts
Study aims to address the critical issue of radiation exposure in cardiology catheterization labs. By comparing the radiation dose received by patients undergoing diagnostic angiography with and without a new low dose exposure protocol, the study seeks to evaluate the effectiveness of this protocol in reducing radiation exposure.
次要结局
未报告次要终点
研究者
Dr Bharat Singh Sambyal
Dr Bharat Singh Sambyal, MD, DM
Institute of Naval Medicine, Indian Naval Hospital Ship (INHS) Asvini