Development of Magnetic Resonance Coronary Angiography (MRCA) Stenosis Assessment Quantification Method by Comparison With Coronary Computed Tomography Angiography (CTA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The SI drop (%) threshold that corresponds to the significant stenosis in coronary CTA.
研究概览
简要总结
Magnetic resonance coronary angiography (MRCA) has its advantage in its ability to assess the coronary artery morphology without radiation or contrast media. The clinical application of MRCA is still challenging mainly because of technical limitations such as: its time-consuming image acquisition, inconsistent image quality, and low spatial resolution. Optimization of MRCA image acquisition method is in progress and compressed sensing (CS) with post-processing (de-noising) by deep learning reconstruction (DLR) is promising to solve these problems.
The lack of a consensus method to assess the coronary stenosis on MRCA is another issue. Generally, a stenosis in MRCA is observed as a signal intensity (SI) drop along the artery compared to the healthy segments. A previous study has reported from its comparison of MRCA with coronary angiography (CAG) that the SI drop of 35% in MRCA stenosis lesion corresponded to the significant stenosis in CAG. Although this SI drop phenomenon was not observed in a different study on chronic total obstruction cases. One of the hypothesized reasons is that the SI drop in MRCA is affected not only by the stenosis severity but also the plaque characteristics, which is not assessable by CAG. To investigate this hypothesis coronary CTA is needed, which is a robust modality to assess coronary stenosis and plaque characteristics. Comparison between MRCA with CTA has the potential to give better information for developing a robust method to assess MRCA.
In this study, the investigators aim to evaluate the feasibility of MRCA scanned with optimized protocol and post-processing, and to develop robust coronary artery assessment method on MRCA, by comparison with clinical coronary CTA.
详细描述
Background:
Diagnosis of significant stenosis of the coronary artery and managing the ischemia is important to prevent cardiac events. Coronary CT angiography (CTA) is one of the current gold standard methods to assess coronary stenosis as well as coronary angiography (CAG), but both coronary CTA and CAG are limited by radiation exposure or contrast media administration.
Magnetic resonance coronary angiography (MRCA) has its advantage in its ability to assess the coronary artery morphology without radiation or contrast media. Unfortunately, the clinical application of MRCA is still challenging mainly because of technical limitation such as its time-consuming image acquisition, inconsistent image quality, and low spatial resolution.
Optimization of MRCA image acquisition process is under great interest and compressed sensing (CS) is one of the promising methods to reduce the acquisition time. Although it's noise-like granular characteristics is a weakness due to its random k-space data acquisition. The granularity may affect the interpretation of the MRCA images considering the small diameter of the coronary arteries. To solve this problem, post-processing denoising approach with deep learning reconstruction (dDLR) is proposed, however too much image smoothing may lead to unfavorable image blurring or produce artefactual smoothing leading to the removal of clinically meaningful signal intensity drops across the artery. Hence, merely assessing the noise level is insufficient. Evaluation of the optimized images with coronary CTA, which is one of the current gold standards, is inevitable to assess its clinical feasibility.
The lack of a consensus method to assess the coronary stenosis on MRCA is another problem. MRCA interpretation is generally performed visually, but its quantification is clinically important to detect the significant stenosis. A previous study has reported by investigating the signal intensity (SI) profile across the coronary artery and its drop of 35% corresponded to significant stenosis by coronary angiography (CAG). Although this SI drop phenomenon was not observed in a different study on chronic total obstruction cases. One of the hypothesized reasons is that the SI drop in MRCA is affected not only by the stenosis severity but also the plaque characteristics, which is not assessable by CAG. To confirm this hypothesis coronary CTA is needed, which is a robust modality to assess coronary stenosis and plaque characteristics. Comparison between MRCA with CTA has the potential to give better information for developing a robust method to assess MRCA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants who underwent clinical coronary CTA within 6 months and allow the study to use the image.
- •Willing to sign a consent.
- •Overall health status is rated as good/healthy other than suspected coronary artery disease
- •Weight is <300 pounds
- •Not claustrophobic
- •Age: 18 or older
- •No clear contraindication against the sublingual nitro administration
排除标准
- •Previous history of bypass surgery or percutaneous coronary intervention (PCI)
- •Metal fragments in the eyes, brain, or spinal cord
- •Internal electrical devices, such as a cochlear implant, spinal cord stimulator, pacemaker, or defibrillator
- •Pregnancy
- •Claustrophobia
- •Unstable angina pectoris patients
- •Taking phosphodiesterase V inhibitors (If the participant is taking this medication for erectile dysfunction and allowed to stop it for 72 hours before the MRI, the participant can be included in this study.)
- •Contraindication to use sublingual nitro administration, such as occlusive glaucoma, known allergy or severe intolerance, critical aortic stenosis. Blood pressure is not included in the exclusion criteria, but when the SBP<110 mmHg just before the cardiac MRI, the participant will not be administered the sublingual nitro.
结局指标
主要结局
The SI drop (%) threshold that corresponds to the significant stenosis in coronary CTA.
时间窗: After the last participant MRI scan, up to 6 months
MRCA signal intensity change compared to the proximal or distal segments of the coronary artery will be measured and compared with corresponding lesion of coronary CTA. The threshold of SI drop (%) which corresponds to the significant stenosis in CTA will be assessed.
次要结局
- Visible coronary length in MRCA(After participant's MRI scan, up to 2 weeks)
- Semi-quantitative image quality assessment score for each segments in MRCA(After participant's MRI scan, up to 2 weeks)
