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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| Astellas Pharma Inc | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | 400ug IV bolus injection, single dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour observation post perfusion |
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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 Medicial Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regadenoson 400 ug IV Bolus Injection | Real time perfusion (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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | 60 Males, 40 Females being evaluated for coronary artery disease. | Posted | Count of Participants | Participants | 1 hour observation post perfusion |
|
1 hour observation
Non-serious adverse persisted no more than 5 minutes for chest pain, shortness of breath & back pain. Headaches were reported within 1 hour.
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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 | Arm One | 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 Non-serious adverse effects during Regadenoson and Definity administration included chest pain in 7% of patients, shortness of breath in 48%, headache in 23% and back pain in 4%. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment | Chest Pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Porter | University of Nebraska Medical Center | 402-559-5151 | 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 |
| C042852 | perflutren |
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| Omaha |
| Nebraska |
| 68105 |
| United States |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Myocardial Perfusion | 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 myocardial perfusion. Myocardial perfusion was assessed by examination of myocardial contrast replenishment after brief high mechanical index impulses. A perfusion defect was defined as a delay (>2 seconds) in myocardial contrast replenishment in 2 contiguous segments. |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 82 |
| 100 |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Shortness of Breath |
|
| Headache | Vascular disorders | Systematic Assessment | Headache |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Back pain |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |