Breathing-Induced Myocardial Oxygenation Reserve
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03050346
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Brief Summary
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.
- Detailed Description
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.
The investigators aim to assess if the breathing-induced relative increase of myocardial oxygenation (Breathing-induced Myocardial Oxygenation REserve, B-MORE) in a coronary territory is clinically feasible to serve as a marker for the severity of coronary artery stenosis.
Moreover, the investigators will assess the feasibility and safety of OS-CMR with breathing maneuvers in patients with suspected coronary artery disease in a multi-center setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 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
- Secondary Outcome Measures
Name Time Method Clinical feasibility of OS-CMR with breathing maneuvers OS-CMR with breathing maneuvers will last about 5-10 minutes Number of participants who voluntarily stopped the maneuver prior to completion and scan time of the image acquisition protocol.
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 Myocardial oxygenation signal intensity changes (OS-SI) changes during OS-CMR with breathing-maneuvers and its relation to Fractional Flow Reserve (FFR) measurements
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 Myocardial oxygenation signal intensity changes (OS-SI) changes during OS-CMR with breathing-maneuvers and its relation to Quantitative Coronary Angiography (QCA) measurements
Presence of side effects during OS-CMR with breathing maneuvers OS-CMR with breathing maneuvers will last about 5-10 minutes side effects experienced by the participants during breathing maneuvers
Trial Locations
- Locations (6)
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
King's College London
🇬🇧London, United Kingdom
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
University of Wisconsin
🇺🇸Madison, Wisconsin, United States