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

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.
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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 |
- 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.
- 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.

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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 |
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.

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
United States, North Carolina | |
WAKE FOREST UNIVERSITY Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | William G Hundley, M.D., F.A.C.C., F.A.H.A | Wake Forest University Health Sciences |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Coronary Artery Disease Coronary Vessels Myocardial Ischemia Coronary Disease |
Ischemic heart disease asthma copd |
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 |