Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2015 |
| End Date: | June 2016 |
| Contact: | Paul J Kim, MD |
| Email: | Pjkim08@stanford.edu |
| Phone: | 650-498-4805 |
Stress Cardiac MRI Using Regadenoson for Evaluation of Nonspecific Allograft Dysfunction
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.
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.
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 Stanford University and Palo Alto
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.
contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be
enrolled over 10 months. Patients will be recruited from Stanford University and Palo Alto
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.
Inclusion Criteria:
- Age greater than or equal to 18 years old.
- At least three months status post heart transplantation.
- Heart-transplant patients with normal graft function (left ventricular ejection
fraction equal to or greater than 55%) and no prior history of clinically significant
acute rejection episodes that required modification of the immunosuppressive regimen
or cardiac allograft vasculopathy.
- Heart-transplant patients with nonspecific allograft dysfunction (left ventricular
ejection fraction equal to or less than 50% AND decrease from post-transplant
baseline ejection fraction by an absolute difference of 10% or greater, no formal
diagnosis of allograft vasculopathy by coronary angiogram or coronary vascular
ultrasonography, and no history of prior acute rejection episodes known to have
decreased left ventricular ejection fraction to or less than 50%).
Exclusion Criteria:
- Biopsy proven acute rejection episode in the past 3 months.
- Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary
syndrome in the past 3 months.
- Uncontrolled obstructive ventilatory disease including asthma and COPD.
- Second or third degree AV nodal block.
- Sinus node dysfunction.
- Contraindications to MRI including pacemakers or implantable
cardioverter-defibrillators.
- Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2.
- Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse
reaction to adenosine will be assessed on a case-by-case basis.
- Any invasive procedure, including endomyocardial biopsy and left coronary angiogram,
performed within one week.
- Systolic blood pressure greater than 180 or less than 85 mmHg.
- Diastolic blood pressure greater than 120 or less than 40 mmHg.
- Resting heart rate greater than 120 or less than 45 beats per minute.
- Severe claustrophobia.
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