Regadenoson R-T Perfusion Imaging Trial
This study has been completed.
Sponsor:
University of Nebraska
Collaborators:
Mayo Clinic
Astellas Pharma Inc
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00837369
First received: February 3, 2009
Last updated: July 19, 2012
Last verified: July 2012
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Purpose
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the A2A Receptor 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
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease Myocardial Perfusion Abnormalities |
Drug: Regadenoson |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Regadenoson Real Time Perfusion Imaging Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Regadenoson
U.S. FDA Resources
Further study details as provided by University of Nebraska:
Primary Outcome Measures:
- more feasible and accurate way to detect significant coronary artery disease [ Time Frame: upon completion of the study ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
Drug: Regadenoson
400ug IV bolus injection, single dosage
Other Names:
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- Pregnancy or lactation.
- Complicated hemodynamic instability (i.e., 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.
- 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837369
Locations
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| University of Nebraska Medicial Center | |
| Omaha, Nebraska, United States, 68105 | |
Sponsors and Collaborators
University of Nebraska
Mayo Clinic
Astellas Pharma Inc
More Information
No publications provided
| Responsible Party: | Thomas R. Porter, MD, Professor, University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00837369 History of Changes |
| Other Study ID Numbers: | 566-08-FB |
| Study First Received: | February 3, 2009 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Nebraska:
|
Stress echocardiography SPECT Myocardial perfusion imaging |
Additional relevant MeSH terms:
|
Congenital Abnormalities Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Regadenoson Adenosine A2 Receptor Antagonists Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013