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| Name | Class |
|---|---|
| Astellas Pharma Global Development, Inc. | INDUSTRY |
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The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.
This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adenoscan | Active Comparator | Subjects will have the FFR Measurement with IV Adenoscan® |
|
| Regadenoson | Experimental | Subjects will have the FFR Measurement with IV Regadenoson |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR Measurement with IV Adenoscan® then with Regadenoson | Drug | Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing Measurement of Fractional Flow Reserve (FFR) | For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded. | DAY 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration to Baseline Hyperemia After Aminophylline Injection | In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection | seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bober, MD | Ochsner Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adenoscan + Regadenoson | Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson FFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adenoscan + Regadenoson | Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson FFR Measurement with IV Adenoscan® then with Regadenoson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny. |
| 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 | Comparing Measurement of Fractional Flow Reserve (FFR) | For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded. | Posted | Mean | Standard Deviation | FFR | DAY 1 |
|
Subjects were monitored during and post-procedure until discharge from the procedure. This duration was less than 24 hours for each participant.
Definitions do not differ.
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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 | Adenoscan | Subjects will have the FFR Measurement with IV Adenoscan® FFR Measurement with IV Adenoscan®: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Bober | Ochsner Clinic Foundation | 504-842-4135 | rbober@ochsner.org |
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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 |
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|
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| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Regadenoson | Subjects will have the FFR Measurement with IV Regadenson FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. |
|
|
| Secondary | Duration to Baseline Hyperemia After Aminophylline Injection | In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection | Of the 48 patients enrolled, 7 of the patients did not have measurements for the secondary outcome. | Posted | Mean | Standard Deviation | seconds | seconds |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Regadenson | Subjects will have the FFR Measurement with IV Regadenson FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. | 0 | 48 | 0 | 48 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |