Breathing-Induced Myocardial Oxygenation Reserve - Pilot Study (B-MORE-Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 6
- 主要终点
- Comparison of myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers in CAD patients.
研究概览
简要总结
This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol, combined with a specific breathing maneuver to identify myocardial regions exposed to severe coronary artery stenosis.
详细描述
This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol. It aims to investigate a new Cardiovascular Magnetic Resonance (CMR) technique, called oxygenation-sensitive CMR (OS-CMR).
OS-CMR is a T2*-sensitive CMR sequence based on the so-called blood-oxygen-level-dependent (BOLD) effect. Because de-oxygenated hemoglobin acts as an endogenous paramagnetic contrast agent, the signal intensity (SI) in OS-CMR images is linearly correlated with hemoglobin oxygenation in the tissue. An increase in deoxyhemoglobin results in an drop in SI in OS-CMR images, while an increase in tissue oxygenation results in an increase in SI.
Therefore, OS-CMR has been found capable of assessing myocardial oxygenation and is being increasingly used to identify the vascular response of the coronary circulation to different stimuli.
Very recently, OS-CMR was used to identify the coronary vascular response to specific breathing maneuvers. Specifically, a marked increase of myocardial oxygenation was observed during a long breath-hold following a 60s period of hyperventilation. The combination of these two maneuvers appear to induce consistent and detectable changes of myocardial oxygenation, based on CO2-mediated coronary vasoconstriction and vasodilation, while being well tolerated by participants.
In this study, the investigators will use breathing maneuvers as coronary vasoactive stimuli to assess the myocardial oxygenation changes induced by such maneuvers with 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 > 18 y
- •Informed consent as documented by signature (Appendix Informed Consent Form)
- •Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia
- •One-vessel or two-vessel CAD at coronary angiography (For healthy volunteers: absence of current or pre-existing cardiovascular and lung disease and absence of medication with cardiovascular effects)
排除标准
- •General MRI contraindications (i.e pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy)
- •Acute Coronary Syndrome (ACS) or other acute cardiac injury within 4 weeks
- •Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass surgery
- •Hemodynamically unstable conditions
- •Significant or uncontrolled arrhythmias
- •Lack of ability to follow commands
- •Vasoactive medication (e.g. nitro or ß blockers) or nutrition with caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 h before the exam
- •Non-ischemic cardiomyopathy
- •Severe Pulmonary Disease
结局指标
主要结局
Comparison of myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers in CAD patients.
时间窗: OS-CMR with breathing maneuvers will last about 5-10 minutes
Myocardial oxygenation signal intensity changes (OS-SI) changes between healthy and post-stenotic myocardium during OS-CMR with breathing-maneuvers
次要结局
- Clinical feasibility of OS-CMR with breathing maneuvers(OS-CMR with breathing maneuvers will last about 5-10 minutes)
- Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Fractional Flow Reserve (FFR) measurements in CAD patients(OS-CMR with breathing maneuvers will last about 5-10 minutes)
- Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Quantitative Coronary Angiography (QCA) measurements in CAD patients(OS-CMR with breathing maneuvers will last about 5-10 minutes)
- Presence of side effects during OS-CMR with breathing maneuvers(OS-CMR with breathing maneuvers will last about 5-10 minutes)
研究者
Matthias Friedrich
Chief, Cardiovascular Imaging, McGill University Health Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre