Comparison of Dobutamine and Regadenoson Stress Cardiac MR
Information source: Wake Forest University Baptist Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease; Asthma; Chronic Obstructive Pulmonary Disease (COPD); Angina
Intervention: Regadenoson, Dobutamine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Wake Forest University Baptist Medical Center Official(s) and/or principal investigator(s):
William G Hundley, M.D., F.A.C.C., F.A.H.A, Principal Investigator, Affiliation: Wake Forest University
Overall contact:
Crosby Moss, Phone: 3367161178, Email: ermoss@wfubmc.edu
Summary
The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an
imaging agent with cardiac MR. If found useful, it will help us establish a protocol for
regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR). We will compare
regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR
stress test with regadenoson and with dobutamine. Our participants will include patients
with history of COPD and Asthma, so it will also help us determine feasibility of
Regadenoson in these patient's subgroups.
Clinical Details
Official title: Comparison of Dobutamine and Regadenoson Stress CMR
Study design: Diagnostic, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Primary outcome: Feasibility/Safety
Secondary outcome: Efficacy
Eligibility
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women aged 40 to 85 years with OBSTRUCTIVE AIRWAY DISEASES (ASTHMA AND COPD)
and a forced expiratory volume (FEV1) > 0. 5.
- Patients should have a clinical indication to undergo cardiac stress test with
dobutamine.
Exclusion Criteria:
- Those with pacemakers, defibrillators, functioning neural stimulator devices or other
implanted electronic devices.
- Ferromagnetic cerebral aneurism clips or other intraorbital and intracranial metal.
- An allergy to Gadolinium or other severe drug allergies.
- Acute myocardial infarction within 3 months.
- Moderate or severe aortic stenosis or other significant valvular disease;
- Claustrophobia.
- High grade (2o or 3o) AV Block.
- Closed ankle glaucoma.
- Participants unable to provide informed consent.
- Renal dialysis (subjects with moderate-to-severe renal impairment defined as eGFR <
60 mL/min.
- A contraindication to receipt of dobutamine.
- Participants with known coronary artery disease will be included with the exception
that patients with left main or narrowings >50% in the distributions of the left
anterior descending, circumflex, and right coronary artery will be excluded.
Locations and Contacts
Crosby Moss, Phone: 3367161178, Email: ermoss@wfubmc.edu
WAKE FOREST UNIVERSITY Baptist Medical Center, Winston Salem, North Carolina 27157, United States
Additional Information
Related publications: Leaker BR, O'Connor B, Hansel TT, Barnes PJ, Meng L, Mathur VS, Lieu HD. Safety of regadenoson, an adenosine A2A receptor agonist for myocardial perfusion imaging, in mild asthma and moderate asthma patients: a randomized, double-blind, placebo-controlled trial. J Nucl Cardiol. 2008 May-Jun;15(3):329-36. Epub 2008 Apr 14. Thomas GS, Tammelin BR, Schiffman GL, Marquez R, Rice DL, Milikien D, Mathur V. Safety of regadenoson, a selective adenosine A2A agonist, in patients with chronic obstructive pulmonary disease: A randomized, double-blind, placebo-controlled trial (RegCOPD trial). J Nucl Cardiol. 2008 May-Jun;15(3):319-28. Epub 2008 Apr 14. Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, Lieu H, Mahmarian JJ, Olmsted A, Underwood SR, Vitola J, Wang W; ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58. Gordi T, Frohna P, Sun HL, Wolff A, Belardinelli L, Lieu H. A population pharmacokinetic/pharmacodynamic analysis of regadenoson, an adenosine A2A-receptor agonist, in healthy male volunteers. Clin Pharmacokinet. 2006;45(12):1201-12. Hendel RC, Bateman TM, Cerqueira MD, Iskandrian AE, Leppo JA, Blackburn B, Mahmarian JJ. Initial clinical experience with regadenoson, a novel selective A2A agonist for pharmacologic stress single-photon emission computed tomography myocardial perfusion imaging. J Am Coll Cardiol. 2005 Dec 6;46(11):2069-75. Epub 2005 Nov 9.
Last updated: September 29, 2008
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