UC San Diego
La Jolla, California, 92037, United States
NCT Number: NCT02597543
The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal graft function. The investigators hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to those with normal graft function.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
La Jolla, California, 92037, United States
Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 10 months. Patients will be recruited from UC San Diego and San Diego Veterans Affairs. The investigators will specifically enroll patients with nonspecific allograft dysfunction and patients with normal graft function.
Brief protocol:
Cardiac MRI is performed. Cine images in standard views are obtained. T2 mapping sequences are performed on short axis images. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for one month after enrollment for MACE.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For use in stress myocardial perfusion imaging.
Other names: Lexiscan
For use in both perfusion imaging and late gadolinium enhancement.
Other names: Magnevist
Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.
Time frame: Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.
Myocardial perfusion reserve calculates the increase in myocardial perfusion after stress in comparison to rest. Outcome measure time frame specifies when the myocardial perfusion reserve was obtained in relation to date of heart-transplant for each patient. This was a one time measurement made after heart-transplantation.
Time frame: 10 months after enrollment (when cardiac MRI was performed)
Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period.
Time frame: 10 months after enrollment (from date of cardiac MRI)
Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months
Time frame: 10 months after enrollment (from date of cardiac MRI)
Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment.
Time frame: Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.
Late gadolinium enhancement demonstrates myocardial scar by cardiac MRI. This is measured the day of the cardiac MRI scan and is a one time measurement. Time frame is measurement of late gadolinium enhancement from date of heart-transplantation.
Time frame: Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.
T1 values are obtained at the time of the cardiac MRI and indicate the amount of myocardial edema. This was a one time measurement. Outcome measure time frame indicates when T1 values of the left ventricle were obtained in relation to heart-transplantation.
Paul Kim
Other
Stress Cardiac MRI Using Regadenoson for Evaluation of Nonspecific Allograft Dysfunction
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