Angina, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Coronary Vessels, Myocardial Ischemia, Coronary Disease, Ischemic heart disease, asthma, copd
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.
Interventions
DRUGRegadenoson
Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit.
DRUGDobutamine
Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.
Sponsors
Astellas Pharma US, Inc.
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Sample Overall Study Sample | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 0 | 1 |
| First Intervention | Did not meeting inclusion/exclusion | 1 | 0 |
| Second Intervention | Adverse Event | 1 | 0 |
| Second Intervention | Physician Decision | 2 | 0 |
Baseline characteristics
| Characteristic | Overall Study Sample |
|---|---|
| Age, Continuous | 69 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 3 |
| other Total, other adverse events | 0 / 9 | 2 / 3 |
| serious Total, serious adverse events | 0 / 9 | 0 / 3 |
Outcome results
Primary
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dobutamine | Duration of Procedures | 48 Minutes |
| Regadenoson | Duration of Procedures | 55 Minutes |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Ease of administration | 2.9 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Patient Comfort | 1.8 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Interruptions during the procedure | 0.5 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Side effects | 2.3 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Level of anxiety while during the procedure | 2.4 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Overall rating of the procedure | 4.3 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Level of anxiety while during the procedure | 1.5 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Ease of administration | 1.9 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Side effects | 1.6 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Patient Comfort | 1.5 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Overall rating of the procedure | 4.1 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire | Interruptions during the procedure | 0.1 units on a scale |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) | Episodes of arrhythmias and bradycardia | 0.6 number of episodes |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) | Episodes of wheezing and SPO2<94% | 0.0 number of episodes |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) | Episodes of arrhythmias and bradycardia | 0.1 number of episodes |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing) | Episodes of wheezing and SPO2<94% | 0.0 number of episodes |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Ease of administration | 3.4 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Patient Comfort | 2.3 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Interruptions during the procedure | 0.6 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Side effects | 2.0 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Side effects | 1.3 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Ease of administration | 1.5 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Interruptions during the procedure | 0.1 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire | Patient Comfort | 1.5 units on a scale |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) | Episodes of hypertension | 1.6 number of episodes |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) | Episodes of arrhythmias and bradycardia | .8 number of episodes |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) | Episodes of wheezing and SPO2<94% | 0.0 number of episodes |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) | Episodes of hypertension | 2 number of episodes |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) | Episodes of arrhythmias and bradycardia | .8 number of episodes |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing) | Episodes of wheezing and SPO2<94% | 0.0 number of episodes |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Patient Comfort | 1.2 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Level of anxiety while during the procedure | 1.8 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Interruptions during the procedure | 0.6 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Overall rating of the procedure | 3.5 units on a scale |
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Level of monitoring | 2.7 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Overall rating of the procedure | 4.3 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Patient Comfort | 1.5 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Level of monitoring | 1.1 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Level of anxiety while during the procedure | 1.3 units on a scale |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire | Interruptions during the procedure | 0.1 units on a scale |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dobutamine | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing) | .2 number of episodes |
| Regadenoson | Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing) | 0.0 number of episodes |