The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.
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.
Study Type
OBSERVATIONAL
Enrollment
350
McGill University Health Center
Montreal, Quebec, Canada
RECRUITINGB-MORE: Diagnostic cut-off - Relative change of myocardial signal intensity
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
Time frame: 2019-2022
30sec B-MORE Cut-off
A student's t-test will assess a cut-off of the Breathing maneuver induced Myocardial Oxygenation REserve (MORE), at the 30s time point of the breath hold, for a region perfused by a stenosed coronary artery (FFR / iFR or QCA \>0.75) as compared to a healthy coronary artery (FFR / iFR or QCA \<0.75), within a patient.
Time frame: 2019-2022
Heart rate response to hyperventilation.
Markers of diagnostic accuracy will be obtained to assess the accuracy the heart rate response to hyperventilation.
Time frame: 2019-2022
Myocardial strain response at the 15s and 30s time point during breath-hold
Markers of diagnostic accuracy will be obtained to assess the accuracy of the myocardial strain response at the 15s and 30s time point of the breath-hold
Time frame: 2019-2022
Accuracy of B-MORE and strain response at the 15s and 30s time point of the breath-hold
Markers of diagnostic accuracy will be obtained to assess the accuracy of a combination of the B-MORE and the strain response at the 15s and 30s time point of the breath-hold
Time frame: 2019-2022
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B-MORE - strain response at 15s and 30s time breath hold and Heart rate response
Markers of diagnostic accuracy will be obtained to assess the accuracy of a combination of the B-MORE, the strain response at the 15s and 30s time point of the breath-hold, and the heart rate response to hyperventilation
Time frame: 2019-2022
Relationship between B-MORE vs heart rate response to hyperventilation
A student's t-test will assess the relationship between B-MORE results and heart rate response to hyperventilation
Time frame: 2019-2022
Relationship between myocardial strain and Heart rate
A student's t-test will assess the relationship between the strain response at the 15 and 30 s timepoints and heart rate response to hyperventilation
Time frame: 2019-2022
Relationship between B-MORE and myocardial strain measurements -each coronary territory
A student's t-test will assess the relationship between B-MORE results and myocardial strain measurements (circumferential, longitudinal, and radial) at the 15s and 30s time point for each coronary territory.
Time frame: 2019-2022
Global relationship between B-MORE results and myocardial strain measurements
A student's t-test will assess the global relationship between B-MORE results and myocardial strain measurements (circumferential, longitudinal, and radial).
Time frame: 2019-2022
Relationship between B-MORE and QCA
Pearson's correlation coefficient will be obtained to assess the relationship between B-MORE results at the 15s and 30s time point of the breath-hold and Quantitative Coronary Angiography (QCA) measurements for each coronary territory.
Time frame: 2019-2022
Relationship between B-MORE and FFR / iFR
Pearson's correlation coefficient will be obtained to assess the relationship between B-MORE results at the 15 s and 30s time point of the breath-hold and FFR / iFR measurements for each coronary territory.
Time frame: 2019-2022
Relationship between B-MORE (15s and 30s) vs QCA
Pearson's correlation coefficient will be obtained to assess the relationship between B-MORE results after hyperventilation and Quantitative Coronary Angiography (QCA) measurements for each coronary territory.
Time frame: 2019-2022
Relationship between B-MORE vs FFR - iFR each coronary territory
To assess the relationship between B-MORE results after hyperventilation and FFR / iFR measurements for each coronary territory.
Time frame: 2019-2022
Relationship between B-MORE vs T1/T2 mapping
Pearson's assess the relationship between B-MORE results and global T1/T2 mapping measurements.
Time frame: 2019-2022
Breathing maneuver - Clinical feasibility
Recorded time, exclusion rate due to inability to perform the breathing maneuvers, will be reported for clinical feasibility during MRI and while performing iFR. Any serious adverse effects of the breathing maneuver will be reported for safety.
Time frame: 2019-2022
B-MORE analysis intra and inter-reader reproducibility
Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of B-MORE.
Time frame: 2019-2022