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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00763035
• Collaborator: Astellas Pharma US, Inc. (Industry)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 25.9
• Patients Per Site Per Month: 0.5

Study Details

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

• Study Type: Interventional
• 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: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Mar 1, 2011

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 Names: 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 Names: 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 Names: 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 Names: Dobutrex

Outcome Measures

Primary Outcome Measures

1. Duration of Procedures [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

1. Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire [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.

2. Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) [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.

3. Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire [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.

4. Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing) [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.

5. Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire [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.

6. Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) [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

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00763035
• Other Study ID Numbers: IRB00006484
• First Posted: Sep 30, 2008
• Last Update Posted: Sep 26, 2018
• Last Verified: Sep 1, 2018

• 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: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Dobutamine; Regadenoson

Study Results

Participant Flow

Arm/Group Title	Active Comparator: A: Dobutamine Test Then Regadenoson Test	Active Comparator: B Regadenoson Test Then Dobutamine
Arm/Group Description	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.	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.
Period Title: First Intervention
STARTED	10	4
COMPLETED	9	3
NOT COMPLETED	1	1
Period Title: First Intervention
STARTED	9	3
COMPLETED	6	3
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Overall Study Sample
Arm/Group Description	Overall Study Sample
Overall Participants	14
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	69
Sex: Female, Male (Count of Participants)
Female	5 35.7%
Male	9 64.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 21.4%
White	11 78.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Duration of Procedures
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dobutamine	Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing	All participants that completed the regadenoson testing
Measure Participants	12	9
Mean (Full Range) [Minutes]	48	55

2. Secondary Outcome

Title	Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dobutamine	Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing	All participants that completed the regadenoson testing
Measure Participants	12	9
Ease of administration	2.9	1.9
Patient Comfort	1.8	1.5
Interruptions during the procedure	0.5	0.1
Side effects	2.3	1.6
Level of anxiety while during the procedure	2.4	1.5
Overall rating of the procedure	4.3	4.1

3. Secondary Outcome

Title	Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing)
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dobutamine	Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing	All participants that completed the regadenoson testing
Measure Participants	12	9
Episodes of arrhythmias and bradycardia	0.6	0.1
Episodes of wheezing and SPO2<94%	0.0	0.0

4. Secondary Outcome

Title	Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dobutamine	Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing	All participants that completed the regadenoson testing
Measure Participants	12	9
Patient Comfort	1.2	1.5
Interruptions during the procedure	0.6	0.1
Level of monitoring	2.7	1.1
Level of anxiety while during the procedure	1.8	1.3
Overall rating of the procedure	3.5	4.3

5. Secondary Outcome

Title	Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dobutamine	Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing	All participants that completed the regadenoson testing
Measure Participants	12	9
Mean (Full Range) [number of episodes]	.2	0.0

6. Secondary Outcome

Title	Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dobutamine	Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing	All participants that completed the regadenoson testing
Measure Participants	12	9
Ease of administration	3.4	1.5
Patient Comfort	2.3	1.5
Interruptions during the procedure	0.6	0.1
Side effects	2.0	1.3

7. Secondary Outcome

Title	Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing)
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dobutamine	Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing	All participants that completed the regadenoson testing
Measure Participants	12	9
Episodes of hypertension	1.6	2
Episodes of arrhythmias and bradycardia	.8	.8
Episodes of wheezing and SPO2<94%	0.0	0.0

Adverse Events

Arm/Group Title	Dobutamine		Regadenoson
Arm/Group Description	All participants that completed Dobutamine testing		All participants that completed the regadenoson testing
All Cause Mortality
	Dobutamine		Regadenoson
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/3 (0%)
Serious Adverse Events
	Dobutamine		Regadenoson
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Dobutamine		Regadenoson
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		2/3 (66.7%)
Gastrointestinal disorders
Abdominal Complaints	0/9 (0%)	0	1/3 (33.3%)	1
Nervous system disorders
Headache	0/9 (0%)	0	1/3 (33.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.