Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson

NCT01779869 | Completed Phase 4 Results

• 1 other identifier: PET/MR-Perfusion
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ischemic Heart Disease

Keywords

PET MR myocardial perfusion imaging

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Cardiac PET/MRI Examination

  The accuracy of the cardiac PET and cardiac MR examination components of the PET/MRI, and the accuracy of the combined PET/MR examination, for ischemic heart disease will be compared to the accuracy of cardiac SPECT in patients who have had ICA as "truth" or the reference standard. To assess the accuracy of an abbreviated PET/MR examination, an additional accuracy analysis was made using only the stress PET perfusion imaging and the MR LGE data sets. The accuracy of this combined data set was also determined with ICA as "truth" or the reference standard. Accuracy is calculated as % difference = (experimental - true) x 100%.

  PET/MRI imaging was performed within 10 days after SPECT-MPI examination

Study Arms (1)

Single group assignment - imaging

EXPERIMENTAL

All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson.

Drug: Regadenoson

Interventions

Regadenoson DRUG

Regadenoson 400 micrograms will be administered in a single IV bolus (\<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging.

Also known as: Lexiscan

Single group assignment - imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Center for Clinical Imaging Research at Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Pamela K. Woodard, M.D.
• Organization: Washington University School of Medicine

woodardp@wustl.edu

314-362-7130

Study Officials

• Pamela K Woodard, MD, BA

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Clinical Imaging Research (CCIR)

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 15, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)