A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,130
- 试验地点
- 1
- 主要终点
- Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease
研究概览
简要总结
This study aims to identify and assess new CMR techniques that can improve current CMR protocols.
详细描述
The aim of this study is to develop a comprehensive 10-minute protocol based on function and myocardial tissue characterization without the need for contrast injection, which can be standardized for 70% of cardiac patients.
To test this 10-minute CMR protocol for its ability to significantly improve diagnostic decision-making and to reduce cost.
To test its clinical feasibility, performance and cost-effectiveness in different populations including: Non-ischemic cardiomyopathies (-)OS-CMR and Ischemic Heart Disease and CAD (+)OS-CMR
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Age: > 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system
排除标准
- •General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.Regular nicotine consumption during the last 6 months
- •Inclusion Criteria:
- •Age: >18 y, Informed consent, Clinically indicated CMR exam
- •Exclusion Criteria:
- •General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.
- •Regular nicotine consumption during the last 6 months
结局指标
主要结局
Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease
时间窗: 2019-2025
(Patients with suspected coronary artery disease:) Agreement of the main finding regarding the presence of a coronary territory at risk for inducible myocardial ischemia myocardial derived from OS-CMR, compared with standard first-pass perfusion CMR, using the coronary angiography report as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR first pass perfusion scan will be used as the standard of truth.
Primary diagnosis comparison between SMART CMR and standard CMR
时间窗: 2019-2025
(All patients) Agreement of the suggested primary diagnosis derived from SMART CMR, compared with the diagnosis established from standard CMR protocols, using the final clinical diagnosis as established by the treating physician, as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR protocol will be used as the standard of truth.
次要结局
- SMART CMR scan completion percentage(2019-2025)
- Adverse event monitoring during SMART CMR sequences(2019-2025)
- Adverse event monitoring during OS-CMR sequence(2019-2025)
- OS-CMR scan completion percentage(2019-2025)
- SMART CMR sequence times vs standard protocol sequence times(2019-2025)
- Septal myocardial T2 vs standard myocardial T2(2019-2025)
- OS-CMR sequence times vs standard protocol sequence times(2019-2025)
- Cost comparison of OS-CMR vs standard CMR protocol(2019-2025)
- Septal myocardial T1 vs standard myocardial T1(2019-2025)
- SMART-CMR post-stenotic peak flow vs standard CMR flow images(2019-2025)
- Inter- and intra-scanner variability(2019-2025)
- Cost comparison of SMART CMR vs standard CMR protocol(2019-2025)
- Intra- and inter-reader reproducibility(2019-2025)
- Quantitative parameter comparison between SMART CMR and CINE images(2019-2025)
- Strain measurements vs standard cine image measurements(2019-2025)
研究者
Matthias Friedrich
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre