Coronary Artery DiseaseEarly Phase 1NCT00763035
Comparison of Dobutamine and Regadenoson Stress Cardiac Magnetic Resonance (MR)
A Early Phase 1 study testing Regadenoson and Dobutamine in people with Coronary Artery Disease and Asthma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Asthma, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Regadenoson and Dobutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2011
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
WAKE FOREST UNIVERSITY Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Comparison of Dobutamine and Regadenoson Stress CMR
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.
- Being tested
- Regadenoson, Dobutamine
- Keywords
- Coronary Artery Disease, Coronary Vessels, Myocardial Ischemia, Coronary Disease, Ischemic heart disease, asthma, copd
- Medical subject headings
- Coronary Artery Disease, Asthma, Pulmonary Disease, Chronic Obstructive, Angina Pectoris, Myocardial Ischemia, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegadenosonDrug
Also called Lexiscan
Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit.
DobutamineDrug
Also called Dobutrex
Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 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. Receives: Drug: Regadenoson; Drug: Dobutamine |
| B | Active comparator | 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. Receives: Drug: Regadenoson; Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionMar 2011
Why it stopped: Potential participants with COPD/asthma unwilling to participate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Sponsor
- Investigators
- William G Hundley, M.D., F.A.C.C., F.A.H.A, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763035
- Sponsor's protocol ID
- IRB00006484
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2008
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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. doi: 10.1016/j.nuclcard.2008.02.009. Epub 2008 Apr 14.
PubMed 18513639Thomas 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.
PubMed 18513638Iskandrian 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. doi: 10.1016/j.nuclcard.2007.06.114.
PubMed 17826318Gordi 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. doi: 10.2165/00003088-200645120-00005.
PubMed 17112296Hendel 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. doi: 10.1016/j.jacc.2005.05.097. Epub 2005 Nov 9.
PubMed 16325044
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dobutamine and Regadenoson Stress CMR
- ClinicalTrials.gov ID
- NCT00763035
- Acronym / sponsor ID
- IRB00006484
- Keywords
- Coronary Artery Disease, Coronary Vessels, Myocardial Ischemia, Coronary Disease, Ischemic heart disease, asthma, copd
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Potential participants with COPD/asthma unwilling to participate.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 26 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Regadenoson, Drug: DobutamineArm 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. |
| B | Active comparator | Drug: Regadenoson, Drug: DobutamineArm 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegadenosonAlso: LexiscanEach participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit. | Drug | A, B |
| DobutamineAlso: DobutrexEach participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit. | Drug | A, B |
Primary outcome
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.
6 secondary outcomes
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire
Time frame: 1 day
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 Tech Questionnaire
Time frame: 1 day
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)
Time frame: 1 day
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire
Time frame: 1 day
Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing)
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18513639Leaker 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.
- Background: PubMed 18513638Thomas 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.
- Background: PubMed 17826318Iskandrian 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. doi: 10.1016/j.nuclcard.2007.06.114.
- Background: PubMed 17112296Gordi 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. doi: 10.2165/00003088-200645120-00005.
- Background: PubMed 16325044Hendel 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. doi: 10.1016/j.jacc.2005.05.097. Epub 2005 Nov 9.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William G Hundley, M.D., F.A.C.C., F.A.H.A principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Regadenoson and Dobutamine in people with Coronary Artery Disease and Asthma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Procedures (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00763035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.