Clinical trial NCT00763035: Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)
Official title: Comparison of Dobutamine and Regadenoson Stress CMR
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Coronary Artery Disease
Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Angina
Keywords: Coronary Artery Disease
Coronary Vessels
Myocardial Ischemia
Coronary Disease
Ischemic heart disease
asthma
copd
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2008-09-30
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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).The investigators will compare regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR stress test with regadenoson and with dobutamine. The investigators 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.


Eligibility 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 angle 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.

Primary outcomes:
measure: Duration of Procedures
timeFrame: 1 day
Secondary outcomes:
measure: Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire
timeFrame: 1 day
measure: Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing)
timeFrame: 1 day
measure: Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire
timeFrame: 1 day
measure: Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)
timeFrame: 1 day
measure: Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire
timeFrame: 1 day
measure: Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing)
timeFrame: 1 day
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: WAKE FOREST UNIVERSITY Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: William G Hundley, M.D., F.A.C.C., F.A.H.A
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.nuclcard.2008.02.009. Epub 2008 Apr 14.
citation: 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. doi: 10.1016/j.nuclcard.2008.02.013. Epub 2008 Apr 14.
citation: 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. doi: 10.1016/j.nuclcard.2007.06.114.
citation: 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. doi: 10.2165/00003088-200645120-00005.
citation: 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. doi: 10.1016/j.jacc.2005.05.097. Epub 2005 Nov 9.