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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
| GE Healthcare | INDUSTRY |
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The purpose if this study is to examine how effective Regadenoson is in detecting coronary artery disease during a stress echocardiogram when Optison is administered. Optison is a contrast agent that improves the images of the heart on the echocardiogram (echo) machine. Optison is approved by the Food and Drug Administration (FDA) to use during stress echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is used to chemically increase the heart rate and is approved for nuclear imaging tests. Regadenoson is a FDA approved drug but not for the intended use in this study.
Stress perfusion imaging has primarily been done with radionuclide scintigraphy or single photon emission computed tomography (SPECT) and has not reached its full clinical potential because of the poor spatial resolution of SPECT, increased expense of this procedure, patient exposure to ionizing radiation, and lack of availability. The A2A receptor agonist Regadenoson has been utilized to detect myocardial perfusion abnormalities during SPECT myocardial perfusion imaging.
A 100 patient pilot study (Regadenoson Real Time Perfusion Imaging Trial, IRB #566-08-FB) demonstrated the feasibility and accuracy of real-time perfusion echocardiography (RTPE) in detecting coronary artery disease following Regadenoson bolus injection and Definity as an ultrasound contrast agent. The aim of this study is to determine whether similar feasibility and accuracy can be achieved with Optison (a Food and Drug Administration approved ultrasound contrast agent that differs slightly in microbubble size and composition) in detecting coronary artery disease (CAD) following Regadenoson bolus injection. As with the original study, sensitivity, specificity, and accuracy of perfusion and wall motion analysis to identify a coronary stenosis >50% in diameter by quantitative angiography will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regadenoson; Optison | Experimental | Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson; Optison | Drug | A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Coronary Stenosis | Measurements will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R Porter, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| University of Nebraska Medical Center |
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| Label | URL |
|---|---|
| Journal of the American Society of Echocardiography | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regadenoson; Optison | Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. Regadenoson; Optison: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regadenoson; Optison | Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. Regadenoson; Optison: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Coronary Stenosis | Measurements will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography. | Posted | Count of Participants | Participants | 1 year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regadenoson; Optison | Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography. Regadenoson; Optison: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas R Porter | University of Nebraska Medical Center | 402-559-5156 | trporter@unmc.edu |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
| C099458 | FS 069 |
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| Omaha |
| Nebraska |
| 68105 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Inter-Quartile Range | kg/m2 |
|
| Percutaneous coronary intervention (PCI) Coronary artery bypass surgery (CABG) | Percutaneous coronary intervention (PCI) Coronary artery bypass surgery (CABG) | Count of Participants | Participants |
|
| Hypertension | Number | participants |
|
| Hyperlipidemia | Number | participants |
|
| Diabetes | Count of Participants | Participants |
|
| Resting ejection fraciton (%) | Log Mean | Inter-Quartile Range | percent |
|
| Resting heart rate, bpm | Mean | Full Range | beats per minute |
|
| Peak heart rate, bpm | Mean | Inter-Quartile Range | beats per minute |
|
| Resting SBP, mm Hg | Mean | Inter-Quartile Range | mm Hg |
|
| Peak SBP, mm Hg | Mean | Inter-Quartile Range | mm Hg |
|
| Resting DBP, mm Hg | Mean | Inter-Quartile Range | mm Hg |
|
| Peak Diastolic Blood Pressure (DBP) | Mean | Inter-Quartile Range | mm Hg |
|
| Resting Rate Pressure Product (RPP) | Mean | Standard Deviation | beats/minute*mmHg |
|
| Peak Rate Pressure Product (RPP) | Mean | Standard Deviation | beats/minute*mmHg |
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 50 |
| 50 |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headaches | General disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |