Breathing-Maneuver-Induced Myocardial Oxygenation Reserve Validated by FFR (B-MORE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity
研究概览
简要总结
The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.
详细描述
This observational applied research international study aims to assess the validity of breathing maneuvers as a vasoactive maneuver and Oxygenation-Sensitive Cardiac Magnetic Resonance Imaging (OS-CMR) in a patient population. OS-CMR results will be compared to the clinical gold standard of Fractional Flow Reserve (FFR) and instant wave-free ratio (iFR) as a secondary objective, to determine if this non-invasive, no pharmaceutical agent imaging technique can identify areas of oxygenation deficit in myocardium perfused by a stenosed coronary artery.
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
- •Healthy Participants
- •Age: > 40y
- •No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system.
- •CAD Patients
- •Age > 18 y
- •Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.
排除标准
- •ALL participants:
- •General MRI contraindications: Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
- •Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam.
- •Regular nicotine consumption during the last 6 months.
- •Patients only
- •Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam Contraindications to adenosine (2nd or 3rd A-V block, sinus node disease, asthma, bronchoconstrictive diseases).
- •Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
- •Previous myocardial infarction within 1 month
- •Clinically unstable condition
- •Significant or uncontrolled arrhythmia
结局指标
主要结局
B-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity
时间窗: 2019-2022
To obtain a diagnostic cut-off of the mean Breathing-Maneuver-induced Myocardial Oxygenation REserve (B-MORE) of a coronary territory as defined by the relative change of myocardial signal intensity (delta SI\[%\]) in oxygenation-sensitive CMR (OS-CMR) images, at the 15s and 30s time point of a post-hyperventilation breath-hold for detecting an associated severe coronary artery stenosis as defined by FFR of less than 0.75 or a QCA assessment of \>0.75, as compared to the global delta SI\[%\] in age-matched healthy volunteers
次要结局
- 30sec B-MORE Cut-off(2019-2022)
- Relationship between B-MORE and QCA(2019-2022)
- Relationship between B-MORE and FFR / iFR(2019-2022)
- Heart rate response to hyperventilation.(2019-2022)
- Myocardial strain response at the 15s and 30s time point during breath-hold(2019-2022)
- Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold(2019-2022)
- B-MORE - strain response at 15s and 30s time breath hold and Heart rate response(2019-2022)
- Relationship between B-MORE vs heart rate response to hyperventilation(2019-2022)
- Relationship between myocardial strain and Heart rate(2019-2022)
- Relationship between B-MORE and myocardial strain measurements -each coronary territory(2019-2022)
- Global relationship between B-MORE results and myocardial strain measurements(2019-2022)
- Relationship between B-MORE (15s and 30s) vs QCA(2019-2022)
- Relationship between B-MORE vs FFR - iFR each coronary territory(2019-2022)
- Relationship between B-MORE vs T1/T2 mapping(2019-2022)
- Breathing maneuver - Clinical feasibility(2019-2022)
- B-MORE analysis intra and inter-reader reproducibility(2019-2022)
研究者
Matthias Friedrich
Cardiologist
McGill University Health Centre/Research Institute of the McGill University Health Centre