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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01162 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Astellas Scientific & Medical Affairs, Inc. | INDUSTRY |
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The goal of this clinical research study is to compare regadenoson nuclear stress testing with echocardiography strain measurements (an ultrasound imaging method that measures hearts function) in detecting coronary artery disease.
If you agree to take part in this study, you will have the echocardiography strain measurement performed. This will be done while you lie on an exam table. An ultrasound technician will apply a vaseline-like gel to your chest and will take the measurements by holding a transducer (a device that resembles a microphone) against your chest, sliding it back and forth. This will take about 10 minutes.
After the resting strain measurement is done, you will have the first set of nuclear images. This will be done just like the echocardiography strain measurement. Once these images are completed, you will be given regadenoson by vein over about 10 seconds. Within 2 to 4 minutes of receiving the regadenoson, measurements will be repeated. These measurements will take about 2 minutes to complete. At about 30 minutes after regadenoson was given, you will have the final images for the nuclear portion of the testing (this is the usual timing for nuclear images after regadenoson).
You will receive the same treatment during your stress test, including the same amount of regadenoson, as you would if you did not take part in this study. Some participants may be asked to allow a repeat of the strain measurements that will include an additional dose of regadenoson if the first set of images are not good enough and additional images may be taken.
Length of Study:
Your participation on this study will be over 30 days after the tests OR after surgery, whichever occurs later. Researchers will collect information from your medical record for up to 30 days after your tests.
If you have surgery or are hospitalized in the 30 days after the tests, you will be called and asked about any problems you have been having. This call should take about 10 minutes.
This is an investigational study. Regadenoson is FDA approved and is routinely used for nuclear perfusion stress testing. The use of strain measurement during an echocardiogram to detect coronary disease is investigational.
Up to 300 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTE Cardiac Imaging | Experimental | Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete. |
|
| SPECT Cardiac Imaging | Other | After resting strain measurement done, first set of nuclear images taken. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving Regadenoson, measurements repeated. These measurements take about 2 minutes to complete. At about 30 minutes after Regadenoson given, participant will have final images for the nuclear portion of the testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | 0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia | As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Event Rates After ReSTE and SPECT Imaging | Cardiac events after ReSTE and SPECT imaging included myocardial infarction,heart failure, sudden cardiac death, cerebrovascular accident | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas L Palaskas, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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161 participants were approached for the study but 27 participants were excluded. The reasons for exclusion prior to inclusion in the study were as follows: poor quality echocardiographic images (24 patients), patient withdrew consent (2 patients), surgery canceled (1 patient)
Patients were recruited from the cardiac stress laboratory at MD Anderson's main building between 9-30-2014 and 9-7-2018. Patients who were scheduled for a nuclear stress test using regadenoson were evaluated for eligibility and approached for participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: ReSTE Cardiac Imaging | Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: ReSTE Cardiac Imaging | Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete. |
| 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 | Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia | As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients. | Posted | Number | 95% Confidence Interval | proportion of participants | 1 day |
|
30 days after surgery
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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 | Experimental: ReSTE Cardiac Imaging | Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Palaskas, MD | The University of Texas MD Anderson Cancer Center | (713) 745-1942 | nlpalaskas@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2021 | Jul 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Cardiac Event Rates After ReSTE and SPECT Imaging | Cardiac events after ReSTE and SPECT imaging included myocardial infarction,heart failure, sudden cardiac death, cerebrovascular accident | Evaluation of cardiac events within 30 days of surgery for those patients who had SPECT for preoperative evaluation. | Posted | Number | events | 30 days |
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| 0 |
| 134 |
| 0 |
| 134 |
| 0 |
| 134 |
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| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |