Coronary Artery DiseasePhase 1NCT00837369
Regadenoson R-T Perfusion Imaging Trial
A Phase 1 study testing Regadenoson in people with Coronary Artery Disease and Myocardial Perfusion Abnormalities, run by University of Nebraska at 2 sites in United States.
Trial summary
To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Perfusion Abnormalities
- What is being tested?
- Regadenoson
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2009to 1 Dec 2011
- Phase
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female. Age ≥30 years.
- Resting Left Ventricular Ejection Fraction > 40% using Simpson's biplane measurement.
- Scheduled for coronary angiography within 30 days of the Regadenoson stress test.
- Negative urine pregnancy test within 2 hours of ultrasound contrast administration required of females of childbearing age unless post-menopausal or with evidence of surgical sterilization.
- Be conscious and coherent, and able to communicate effectively with trial personnel.
- Agreeable to undergo the additional stress test and coronary angiography
- Have at least an intermediate likelihood of coronary disease based on the following clinical profile
- Good apical echo images with at least 50% of each coronary artery territory well visualized.
Who cannot join
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- Pregnancy or lactation.
- Complicated hemodynamic instability (i.e., New York Heart Association (NYHA) Class IV heart failure, unstable angina at rest despite medical therapy).
- Life expectancy of less than two months or terminally ill.
- Congestive (idiopathic) or hypertrophic cardiomyopathy.
- Known left main disease.
Show all 13Show fewer
- Heart transplant recipient, hypertrophic cardiomyopathy, acute myo- or pericarditis.
- Resting Left Ventricular Ejection Fraction < 40%
- Large inducible perfusion defects or wall motion abnormalities during prior stress imaging study associated with left ventricular cavity dilatation.
- Early positive treadmill EKG within the first stage of the test.
- History of >1st degree heart block, sick sinus syndrome or high grade atrioventricular (AV) block without a pacemaker.
- Dipyridamole use within 30 hours of stress test, or consumption of methylxanthines within 12 hours, or use of sublingual nitroglycerin within two hours.
- Participation In another investigational study within one month of this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska Medicial Center
Omaha, Nebraska, 68105
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Regadenoson Real Time Perfusion Imaging Trial
To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.
Read the detailed description
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in diameter by quantitive angiography will be analyzed
- Being tested
- Regadenoson
- Keywords
- Stress echocardiography, SPECT, Myocardial perfusion imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegadenosonDrug
Also called Definity (Lantheus Medical Imaging), Lipid encapsulated microbubbles
400ug IV bolus injection, single dosage
| Study group | Role | What they receive |
|---|---|---|
| 1 Real time perfusion (RTPE) imaging following Regadenoson | Experimental | RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement. Receives: Drug: Regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress
Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.
Measured: 1 hour observation post perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study start7 Apr 2009
- Primary completion1 Mar 2011
- Study completion1 Dec 2011
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.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Thomas R Porter, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837369
- Sponsor's protocol ID
- 0566-08-FB
- Status last verified
- Dec 2024
- First submitted
- 3 Feb 2009
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regadenoson Real Time Perfusion Imaging Trial
- ClinicalTrials.gov ID
- NCT00837369
- Acronym / sponsor ID
- 0566-08-FB
- Keywords
- Stress echocardiography, SPECT, Myocardial perfusion imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Mayo Clinic, Astellas Pharma Inc
- Study start
- 7 Apr 2009 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 1 Dec 2011 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.
Detailed description
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in diameter by quantitive angiography will be analyzed
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Real time perfusion (RTPE) imaging following Regadenoson | Experimental | Drug: RegadenosonRTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female. Age ≥30 years.
- Resting Left Ventricular Ejection Fraction > 40% using Simpson's biplane measurement.
- Scheduled for coronary angiography within 30 days of the Regadenoson stress test.
- Negative urine pregnancy test within 2 hours of ultrasound contrast administration required of females of childbearing age unless post-menopausal or with evidence of surgical sterilization.
- Be conscious and coherent, and able to communicate effectively with trial personnel.
Key exclusion criteria (13 listed)
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- Pregnancy or lactation.
- Complicated hemodynamic instability (i.e., New York Heart Association (NYHA) Class IV heart failure, unstable angina at rest despite medical therapy).
- Life expectancy of less than two months or terminally ill.
- Congestive (idiopathic) or hypertrophic cardiomyopathy.
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: Definity (Lantheus Medical Imaging), Lipid encapsulated microbubbles400ug IV bolus injection, single dosage | Drug | 1 Real time perfusion (RTPE) imaging following Regadenoson |
Primary outcome
Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress
Time frame: 1 hour observation post perfusion
Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Coronary Artery Disease
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery 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.
Thomas R Porter, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Regadenoson in people with Coronary Artery Disease and Myocardial Perfusion Abnormalities, run by University of Nebraska at 2 sites 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 24 Dec 2024). 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?
Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress (time frame: 1 hour observation post perfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.