Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Contrast Volume after Injection
研究概览
简要总结
The proposed study aims to compare (a) volume contrast administered for Optical Coherence Tomography (OCT) Imaging, (b) length of clear OCT images, and (c) electrocardiographic changes immediately after contrast injection between iso-osmolar and low-osmolar contrast agents. The proposed study is a prospective, single-centered, randomized controlled, study that will compare an iso-osmolar vs. a low-osmolar contrast agent in patients undergoing clinically indicated coronary OCT imaging. Each patient will be randomized to OCT acquisition.
详细描述
Patients referred to the Cardiac Catheterization laboratory for clinically indicated coronary angiography and coronary OCT imaging will be identified by a study team member and screened for eligibility. The proposed study is a prospective, single-center, randomized, controlled, study that will compare an iso-osmolar vs a low-osmolar contrast agent in patients undergoing clinically-indicated coronary OCT imaging. Each patient will be randomized to OCT acquisition. Eligible patients will be approached to obtain informed consent by a member of the study team. Once consent is obtained and inclusion and exclusion criteria are verified, patients are randomized to undergoing OCT image acquisition with iso-osmolar contrast media(IOCM) first or with low-osmolar contrast media first (LOCM).
Then the patients undergo coronary angiography and OCT imaging as per clinical standard of care. However, during the OCT imaging acquisition based on their randomization assignment the patient will undergo the 1st OCT imaging run with either iso-osmolar contrast media or with low-osmolar contrast media. Following this a 2nd OCT imaging run of the same coronary vessel will be done using the other contrast media that was not used during the first run. Therefore, each patient will serve as a comparator to themselves, but also to each other. The electrocardiogram will be recorded during and for 30 seconds after each injection and analyzed offline for detection of any changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Age 18 years or greater
- •Willing and able to give informed consent. The patients must be able to comply with study procedures
- •Undergoing clinically-indicated coronary angiography and OCT
排除标准
- •Baseline electrocardiographic changes hindering interpretation (such as left bundle-branch block, and >1 mm ST segment depression)
- •Emergency cardiac catheterization (for example in patients with ST-segment elevation acute myocardial infarction)
- •Inability to provide symptomatic assessment
- •Known allergy to contrast
研究组 & 干预措施
Iso-Osmolar Contrast Media
Will receive iso-osmolar media first, low-osmolar media second
干预措施: Iodixanol (Drug)
Low-Osmolar Contrast Media
Will receive low-osmolar media first, iso-osmolar media second
干预措施: Iohexol (Drug)
Low-Osmolar Contrast Media
Will receive low-osmolar media first, iso-osmolar media second
干预措施: Iodixanol (Drug)
Iso-Osmolar Contrast Media
Will receive iso-osmolar media first, low-osmolar media second
干预措施: Iohexol (Drug)
结局指标
主要结局
Contrast Volume after Injection
时间窗: 30 seconds after injection
Contrast volume will be measured after each injection
次要结局
- Clear OCT Images(Intra-operative)
- Electrocardiographic (ECG) Changes(During and 30 seconds after injection)