Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective for this pilot study is to develop an optimized, clinically usable myocardial PET-MR perfusion protocol and to determine which of all data potentially available should be acquired for a clinical myocardial perfusion examination. Hypothesis: The hypothesis is that high resolution, high sensitivity DCE MRI could replace the rest PET myocardial perfusion imaging, significantly decreasing examination time and patient radiation dose while maintaining the comprehensive reference-quality PET myocardial stress perfusion coverage.

The primary outcome will be comparison of diagnostic accuracy of each combination of imaging to detect clinically significant coronary artery stenosis (≥70% diameter stenosis).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Regadenoson

Criteria

Inclusion Criteria:

• Patients who have had a clinically ordered rest/regadenoson single-isotope SPECT-MPI study within 10 days prior to cardiac PET-MRI examination

• Reversible perfusion abnormalities on SPECT imaging in at least 2 contiguous myocardial segments

• Patients for whom standard of care coronary ICA is planned

Exclusion Criteria:

• An clinical event (ie; worsening angina pectoris or myocardial infarction) occuring after the SPECT-MPI and before the cardiac MRI examination

• Myocardial revascularization occuring after the SPECT-MPI and before the cardiac MRI examination

• Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, etc.)

• Renal insufficiency (GFR < 60 mL/min/1.73m2)

• Allergy or other contraindication to gadolinium-based MR contrast agent

• Second or third degree atrioventricular (AV) block

• Active asthma

• Seizures

• Current hypotension (<100/60)

• Current hypertension (>160/90)

• Pregnancy

• Breast feeding

• Use of caffeine, nicotine or over the counter cold medicines within 12 hours of the cardiac PET-MRI examination

• Use of the medication dipyridamole within 48 hrs of the cardiac PET-MRI examination