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: Asthma COPD (Chronic Obstructive Pulmonary Disease) Coronary Artery Disease

Drug Information available for: Dobutamine Dobutamine hydrochloride Regadenoson

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

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
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

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 University Baptist Medical Center

Astellas Pharma US, Inc.

Investigators

Principal Investigator:

William G Hundley, M.D., F.A.C.C., F.A.H.A

Wake Forest University

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. 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.

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 University Baptist Medical Center:

Coronary Artery Disease
Coronary Vessels
Myocardial Ischemia
Coronary Disease

Ischemic heart disease
asthma
copd

Additional relevant MeSH terms:

Asthma
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dobutamine
Regadenoson
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists

ClinicalTrials.gov processed this record on May 16, 2013