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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Dobutamine and Regadenoson Stress CMR

Conditions
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Coronary Artery Disease, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Angina

Intervention / Treatment
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* Drug: Regadenoson
* Drug: Dobutamine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br>* Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit.<br>* Other names: Lexiscan;Drug: Dobutamine<br>* Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.<br>* Other names: Dobutrex;|
| Active Comparator: B<br>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<br>* Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit.<br>* Other names: Lexiscan;Drug: Dobutamine<br>* Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.<br>* Other names: Dobutrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Procedures | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | 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. | 1 day | 
| Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) | 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. | 1 day | 
| Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | 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. | 1 day | 
| Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing) | 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. | 1 day | 
| Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | 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. | 1 day | 
| Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Coronary Vessels, Myocardial Ischemia, Coronary Disease, Ischemic heart disease, asthma, copd