Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)

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ClinicalTrials.gov Identifier: NCT00763035

Recruitment Status : Terminated (Potential participants with COPD/asthma unwilling to participate.)

First Posted : September 30, 2008

Results First Posted : September 26, 2018

Last Update Posted : September 26, 2018

Sponsor:

Collaborator:

Astellas Pharma US, Inc.

Information provided by (Responsible Party):

Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease Asthma Chronic Obstructive Pulmonary Disease (COPD) Angina	Drug: Regadenoson Drug: Dobutamine	Early Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Diagnostic
Official Title:	Comparison of Dobutamine and Regadenoson Stress CMR
Study Start Date :	January 2009
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dobutamine Dobutamine hydrochloride Regadenoson

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.	Drug: Regadenoson Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit. Other Name: Lexiscan Drug: Dobutamine Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit. Other Name: Dobutrex
Active Comparator: B Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.	Drug: Regadenoson Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit. Other Name: Lexiscan Drug: Dobutamine Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit. Other Name: Dobutrex

Outcome Measures

Primary Outcome Measures :

Duration of Procedures [ Time Frame: 1 day ]
To compare the time involved during pharmacologic stress testing using regadenoson versus intravenous dobutamine in individuals with moderate to severe chronic obstructive pulmonary disease (COPD)or asthma.

Secondary Outcome Measures :

Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire [ Time Frame: 1 day ]
The Compare MD tool have the following scales: Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure (1 very Difficult to 5 very easy), higher scores represent better outcomes.
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) [ Time Frame: 1 day ]
Ease of Administration of regadenoson versus intravenous dobutamine using Compare MD Questionnaire. Episodes of arrhythmias (including PVCs) and bradycardia (HR<60), low score represent better outcome. Number of Episodes of wheezing and SPO2<94%, low numbers represent better outcome.
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire [ Time Frame: 1 day ]
To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Level of monitoring - Scale from 1(most easy among all MRI tests) to 4(most difficult), low score represent better outcome. Level of anxiety while during the procedure - Scale from 1(less than any other MRI stress test) to 4(the most), low score represent better outcome. Overall rating of the procedure - Scale from 1(very difficult) to 4(very easy), higher scores represent better outcome.
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing) [ Time Frame: 1 day ]
To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Low scores represent better outcome.
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire [ Time Frame: 1 day ]
To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Ease of Administration - Scale from 1(most easy among all MRI stress tests) to 5(most difficult), low score represent better outcome. Patient Comfort - Scale from 1(very comfortable) to 4(very uncomfortable), low score represent better outcome. Interruptions during the procedure - Scale from 1(1-2) to 4(>6), low score represent better outcome. Side effects - Scale from 1(fewer than any other MRI stress test) to 4(the most), low score represent better outcome.
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) [ Time Frame: 1 day ]
To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacological stress testing in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma. Episodes of (SBP>140), low number represent better outcome. Episodes of arrhythmias (including PVCs) and bradycardia (HR<60), low number represent better outcome. Episodes of wheezing and SPO2<94%, low number represent better outcome.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763035

Locations

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United States, North Carolina
WAKE FOREST UNIVERSITY Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Astellas Pharma US, Inc.

Investigators

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Principal Investigator:	William G Hundley, M.D., F.A.C.C., F.A.H.A	Wake Forest University Health Sciences

More Information

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. doi: 10.1016/j.nuclcard.2008.02.009. 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. doi: 10.1016/j.nuclcard.2008.02.013. 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.

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Responsible Party:	Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT00763035
Other Study ID Numbers:	IRB00006484
First Posted:	September 30, 2008 Key Record Dates
Results First Posted:	September 26, 2018
Last Update Posted:	September 26, 2018
Last Verified:	September 2018

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Wake Forest University Health Sciences:


Coronary Artery Disease Coronary Vessels Myocardial Ischemia Coronary Disease	Ischemic heart disease asthma copd

Additional relevant MeSH terms:

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Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Coronary Artery Disease Myocardial Ischemia Coronary Disease Respiratory Tract Diseases Lung Diseases Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Dobutamine Regadenoson Cardiotonic Agents	Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Adenosine A2 Receptor Agonists Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents

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