Breathing-Induced Myocardial Oxygenation Reserve (B-MORE-Pilot)
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|ClinicalTrials.gov Identifier: NCT03050346|
Recruitment Status : Suspended (The preliminary analysis is in progress. Sample size will be revised after data analysis.)
First Posted : February 10, 2017
Last Update Posted : March 21, 2019
|Condition or disease|
|Coronary Artery Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Breathing-Induced Myocardial Oxygenation Reserve - Pilot Study (B-MORE-Pilot)|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Consecutive patients scheduled for a coronary angiography on the basis of cardiac symptoms and a test positive for inducible coronary ischemia, who are affected by one-vessel or two-vessel CAD at the time of the OS-CMR with breathing maneuvers (HVBH).
Subjects without current or pre-existing cardiovascular and lung disease and absence of medication with cardiovascular effects.
- 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. [ Time Frame: 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
- Relationship between OS-SI changes during OS-CMR with breathing-maneuvers and Fractional Flow Reserve (FFR) measurements in CAD patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: OS-CMR with breathing maneuvers will last about 5-10 minutes ]side effects experienced by the participants during breathing maneuvers
- Clinical feasibility of OS-CMR with breathing maneuvers [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050346
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Jewish General Hospital|
|Montreal, Quebec, Canada, 3755|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H4A 3J1|
|University Hospital Heidelberg|
|Heidelberg, Germany, 69120|
|Groote Schuur Hospital|
|Cape Town, South Africa, 7935|
|King's College London|
|London, United Kingdom, WC2R 2LS|
|Principal Investigator:||Matthias Friedrich, MD||McGill University Health Centre/Research Institute of the McGill University Health Centre|