Coronary Artery Disease, Myocardial Perfusion Abnormalities
Conditions
Keywords
Stress echocardiography, SPECT, Myocardial perfusion imaging
Brief 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.
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
Interventions
DRUGRegadenoson
400ug IV bolus injection, single dosage
Sponsors
Mayo Clinic
Astellas Pharma Inc
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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., 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress | 1 hour observation post perfusion | Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regadenoson 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.
Regadenoson: 400ug IV bolus injection, single dosage | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Regadenoson | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 35 Participants | — |
| Age, Categorical Between 18 and 65 years | 65 Participants | — |
| Age, Continuous | 62 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 100 participants | — |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 60 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 82 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
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.
Time frame: 1 hour observation post perfusion
Population: 60 Males, 40 Females being evaluated for coronary artery disease.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wall Motion | Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress | 98 Participants |
| Myocardial Perfusion | Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress | 98 Participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared