Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR) - Full Text View

Purpose

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	Intervention	Phase
Coronary Artery Disease Asthma Chronic Obstructive Pulmonary Disease (COPD) Angina	Drug: Regadenoson, Dobutamine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Comparison of Dobutamine and Regadenoson Stress CMR

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Dobutamine Dobutamine hydrochloride Regadenoson

U.S. FDA Resources

Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:

Duration of procedures [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
To compare the ease of administration of regadenoson verses intravenous dobutamine during pharmacologic stress testin in individuals with moderate to severe chronic obstructive pulmonary disease (COPD) or asthma.


Estimated Enrollment:	40
Study Start Date:	January 2009
Study Completion Date:	March 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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, Dobutamine Cross-over design in which each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit and dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit. Other Name: Lexiscan
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, Dobutamine Cross-over design in which each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit and dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit. Other Name: Lexiscan

Eligibility


Ages Eligible for Study:	40 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763035

Locations


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

Sponsors and Collaborators

Wake Forest Baptist Health

Astellas Pharma US, Inc.

Investigators


Principal Investigator:	William G Hundley, M.D., F.A.C.C., F.A.H.A	Wake Forest School of Medicine

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.


Responsible Party:	WILLIAM GREGORY HUNDLEY MD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00763035 History of Changes
Other Study ID Numbers:	Hundley-2
Study First Received:	September 26, 2008
Last Updated:	July 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wake Forest Baptist Health:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 27, 2016