Regadenoson in stress MRI
|Principal Investigator: BrentWilson|
|Keywords: stress MRI , coronary artery disease , adenosine , regedenoson||Department: Cardiovascular Medicine|
|IRB Number: 00058576||Co Investigator: Edward DiBella|
|Specialty: Cardiology, Radiology, Radiology, Radiology|
|Sub Specialties: Cardiac Imaging, Magnetic Resonance Imaging – MRI|
Objective: To demonstrate sensitivity/specificity comparable to that reported in meta-analyses of non-AF patients and adenosine (90%/80%), in an atrial fibrillation population while using the time-efficient vasodilator regadenoson that requires only a single IV.
Scientific Background/Rationale: Atrial fibrillation (AF) is a large and growing healthcare problem worldwide. Over 7 million people in the U.S. and Europe currently suffer from atrial fibrillation, and this number is expected to double before 2050. The lifetime risk of AF is high: ~24% at age 40, and this risk remains fairly constant at older ages, with 22% lifetime risk at age 80 . AF significantly increases the risk of stroke and mortality, and can greatly limit quality of life. Little research has been done on AF and ischemic cardiomyopathy, though it is a relatively common co-morbidity. CT found increased prevalence (41% vs 27%) of coronary artery disease (CAD) in patients with AF compared to patients with similar pre-test risk but no AF . AF patients with a positive SPECT scan for CAD have a worse prognosis for cardiac events than patients with positive SPECT but without AF . It was recently reported that in a study of 253 AF patients, that AF patients with positive SPECT studies had a very high number of false positives - only 15% of patients had significant CAD by angiography (compared to 67% in the control group) [4, 5]. Just over half of the patients were in sinus rhythm at SPECT, but since similar numbers of positives were seen in each half, the authors did not feel that imaging during AF was the cause of the poor specificity. Use of MRI for assessment of CAD is a growing area that entails no radiation exposure to the patient. Advances in MRI have made it possible to accurately detect CAD, either as well or better than SPECT in unselected populations [6, 7]. However, adoption of MRI myocardial perfusion scans has been limited in part due to the challenges associated with the use of adenosine. Adenosine requires starting a second IV, and to use either a special expensive MRI-compatible infusion pump to deliver the drug, or long lengths of tubing to run to a pump outside the scanner room. Neither solution is ideal, and regadenoson would not require any such pumps or the starting of a second IV. Here we propose to determine the sensitivity/specificity for dynamic contrast-enhanced myocardial perfusion MRI with the vasodilator regadenoson in a subpopulation of patients - those with atrial fibrillation. We have a great deal of experience with stress and rest myocardial perfusion MRI. We have past and currently funded NIH R01 grants that are centered on cardiac perfusion MRI. We also have recently imaged three patients with AF that then went to X-ray angiography (cath). Two of the three subjects had significant stenoses by cath, and one did not. This agreed with the regadenoson stress perfusion MRI findings. Fig. 1 shows the results from one of these patients. These MRI acquisitions were performed on a Siemens Verio MRI scanner. The Verio operates at twice the magnetic field strength (3 Tesla, or 3T) of most MRI scanners, which operate at 1.5T. The higher magnetic field offers images with significantly less noise (almost twice the signal-to-noise ratio). Objective: To demonstrate sensitivity/specificity comparable to that reported in meta-analyses of non-AF patients and adenosine (90%/80% [6, 7]), in an atrial fibrillation population while using the time-efficient vasodilator regadenoson that requires only a single IV. Study Design: This will be a prospective, open-label, comparative trial using MRI. Non-invasive MRI measurements of resting flow and flow at regadenoson stress will be obtained in each subject during a one hour MRI exam using our advanced MRI acquisition techniques. 32 subjects will be recruited for this study. The first two subjects will be imaged only with resting perfusion, in order to determine optimal acquisition parameters for the study, and will not be used in the analysis. Inclusion criteria: Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease that will have corresponding catheterization X-ray angiography data will be recruited to participate in this study. We plan to recruit aggressively and complete the imaging within 12 months after IRB approval.
32 subjects will be recruited for this study. The first two subjects will be imaged only with resting perfusion, in order to determine optimal acquisition parameters for the study, and will not be used in the analysis. Inclusion criteria: Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease that have or plan to have corresponding catheterization X-ray angiography data acquired witin 1 month of the MRI study will be recruited to participate in this study.
Subjects with certain metal implants, including vascular and coronary stents, will be included in this study. Inclusion will be determined on a case by case basis by the P.I. with regards to hospital and manufactures' policies.
Subjects who have a functioning artificial pacemaker will be allowed to participate, even if they have second or third degree AV block or sinus node dysfunction.
Exclusion criteria: Critically ill patients, patients on ventilators, patients with hypotension, asthmatics, and other patients whose medical care or safety may be compromised from undergoing an MRI examination will be excluded. Patients with claustrophobia will also be excluded. Also, anyone with contraindications to MRI (pacemaker, some metal implants), pregnant subjects, minors, and prisoners will be excluded from this study. If subjects are over 60 or have any suspicion of abnormal kidney function, a blood test to determine GFR will be performed prior to imaging. Subjects with GFR<30 will be excluded from the study. This is standard practice for clinical scans in Radiology due to the extremely small but not negligible relationship between gadolinium contrast agent and nephrogenic systemic fibrosis in patients with severely impaired renal function.
All subjects with second or third degree AV block or sinus node dysfunction will be excluded from the study, unless they have a functioning artificial pacemaker.