Phase 4 N=16 Diagnostic

Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

Ischemic Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT01779869 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: Diagnostic Accuracy of Cardiac PET/MRI Examination — 50; 64; 61; 64 percentage — p=0.35

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Regadenoson (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Diagnostic Accuracy of Cardiac PET/MRI Examination	50; 64; 61; 64; 64	0.35

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).

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01779869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.