Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Suitability for routine use measured by imaging time and ease of use
研究概览
简要总结
The purpose of this investigation is to evaluate newer methods of performing cardiovascular MRI (CMR) that will provide new kinds of information related to the interplay between the cardiac and the respiratory cycles, such as the interaction between the left ventricle and the right ventricle during respiration . The primary statistical objective is to provide preliminary indications of the relative utility of the investigational imaging software in terms of image quality and suitability for routine clinical use. Image quality will be expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and subjective Likert-type qualitative assessments independently provided by each of multiple blinded readers for each image. Suitability for routine use will be assessed in terms of imaging time and a binary indicator of whether, in the opinion of the investigator, adverse procedural complications (not expected) were encountered during a given imaging session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 95 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be selected as they are scheduled for clinical MR examinations.
- •Subjects will be selected on the basis of their willingness and ability to participate, on their comprehension of the informed consent document, on their likelihood of completing the study, and on the clinical appropriateness of the investigational technique for a given patient.
排除标准
- •electrical implants such as cardiac pacemakers or perfusion pumps
- •ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- •ferromagnetic objects such as jewelry or metal clips in clothing
- •pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
研究组 & 干预措施
Normal Cardiovascular System
70 with a history of heart or lung disease
干预措施: cardiovascular MRI (CMR) (Procedure)
Abnormal Cardiovascular System
30 without any history of heart or lung disease
干预措施: Conventional Cardiologic Evaluation (Procedure)
结局指标
主要结局
Suitability for routine use measured by imaging time and ease of use
时间窗: 10 Minutes
Image Quality measured by signal to noise
时间窗: 10 Minutes
Image Quality measured by resolution
时间窗: 10 Minutes
次要结局
未报告次要终点