The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.
Age: > 40y
No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system.
Age > 18 y
Indication for invasive coronary angiography based on symptoms and a test positive for inducible coronary ischemia, or previous coronary angiography.
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.
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).
Study population will be composed of patients with suspected or known CAD and healthy volunteers. The primary group will consist of patients with 1- or 2-vessel CAD. Patients diagnosed with 3-vessel or no obstructive disease in an angiography visit after the CMR exam will be included as a sub-group, with not more than 25% of the study population being in this group. Healthy volunteers will serve to act as a control for the assessment of a diagnostic cut-off. Patient who performed the CMR and then the angiography, who are deemed to have no obstructive (no vessel) CAD or 3-vessel CAD, will be assigned to a subgroup of the study. No vessel disease will be those who have no vessel stenosis of \>0.75. 3-vessel disease will be those who have a stenosis of \>0.75 in all three coronary arteries.
Other
Prospective
Not listed
B-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
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.
Heart rate response to hyperventilation.
Markers of diagnostic accuracy will be obtained to assess the accuracy the heart rate response to hyperventilation.
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
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
Click on the lead sponsor to view all of their trials.
