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Low enrollment
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| Name | Class |
|---|---|
| Astellas Pharma Global Development, Inc. | INDUSTRY |
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This study is recruiting patients already scheduled for a single photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) test. SPECT-MPI is a nuclear imaging technique that uses a radioactive substance, or radiotracer, and special equipment to create three-dimensional (3D) images of the heart. Radiotracer is a radioactive dye that will make the structures of the heart visible and is routinely used to view blood flow in the heart, scan for damaged heart tissue, or assess heart function.
For a routine SPECT-MPI test, the radiotracer is given in one dose at the beginning of the test, followed by taking resting images of the heart. For this study, researchers would like to administer half of the radiotracer, obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Participants will receive the same amount of radioactive material that would normally be given for this test; however, it will be administered in two half-doses. Participation in this study will add about 30 minutes to the time it takes to complete the routine test. The investigators expect to enroll about 160 subjects in this study at Northwestern.
Subjects in this study will proceed to the nuclear cardiology laboratory for their scheduled nuclear stress test. After informed consent is obtained, the study doctor or research staff member will ask detailed questions about the subject's current health, medications and medical history, and the subject's medical chart will be reviewed including results of any previous nuclear images.
For the test, a small catheter (tube) will be placed in a vein in the subject's arm to administer the radioactive imaging agent, Tc-99m sestamibi. Subjects will be given half (1/2) of the normal Tc-99m sestamibi dose and then the study staff will obtain resting images pictures of the heart. After this set of images, the subject will be given the remaining half of the radioactive imaging agent followed by a second set of images.
After this, the subject will then undergo the stress portion of the test in the usual manner as prescribed by the referring physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Half-dose radiotracer administration | Experimental | For this study, researchers would like to administer half of the radiotracer, obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Subjects will be given the same amount of radioactive material that would normally be given for this test; however, it will be administered in two ½ doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Half-dose of the Tc99-m sestamibi (Cardiolite) | Drug | Researchers will administer half of the radiotracer (Cardiolite), obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Subjects will be given the same amount of radioactive material that would normally be given for this test; however, it will be administered in two ½ doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Sum Rest Score | Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect. | Baseline |
| Segments With Resting Perfusion Defect | Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality Score | Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent). | Baseline |
| Diagnostic Confidence Score |
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Inclusion Criteria:
Exclusion Criteria:
Unwilling or unable to undergo an additional resting SPECT acquisition
Clinical contraindications to nuclear stress testing including acute myocardial infarction
Left bundle branch block or artificial ventricular pacemaker
Moderate to severe chronic obstructive pulmonary disease or asthma, second- or third degree atrioventricular block or sinus node disease (unless patients have a functioning artificial pacemaker), known hypersensitivity to aminophylline or adenosine
Inability to give informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Edwin Wu, M.D., FACC | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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Prospectively enroll patients with history of severe myocardial infarction, cardiomyopathy, heart failure or prior nuclear scans with resting perfusion defects. Patients were approached in the nuclear stress lab prior to scheduled stress test. Recruitment period was between 3/20/2012 and 2/14/2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Entire cohort |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Entire cohort |
| 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 | Sum Rest Score | Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
Adverse events were only collected during the time frame of the imaging study, ie. between the first 1/2 dose injection and the second imaging scan (Reference Outcome Measures, post-hoc analysis "Injection and Scan Times").
Adverse events for this imaging study would include mis-administration of a tracer dose or errors in acquiring images that would result in an inability to interpret and report the clinical imaging study to the referring physician.
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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 | Study Group | Entire cohort for the study |
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Early termination of study lead to a small numbers of subjects analyzed. Technical problems in WBR processing settings including acquisition matrix sizes and/or number of iterations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwin Wu, MD | Northwestern University | 847-535-7270 | ed-wu@northwestern.edu |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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| ID | Term |
|---|---|
| D017256 | Technetium Tc 99m Sestamibi |
| D013667 | Technetium |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
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|
|
Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent). |
| Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Indications for stress test | Number | participants |
|
| History | Number | participants |
|
| Previous nuclear stress | Number | participants |
|
| Medications | Number | participants |
|
| Half-dose FBP |
Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP) |
| OG002 | Full-dose FBP | Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP) |
|
|
|
| Secondary | Image Quality Score | Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
|
| Secondary | Diagnostic Confidence Score | Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
|
| Primary | Segments With Resting Perfusion Defect | Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect. | Posted | Mean | Standard Deviation | segments | Baseline |
|
|
|
|
| Post-Hoc | Resting Full-Tracer Dose | Amount of the standard, clinically-accepted, full-dose Tc-99m sestamibi dose administered | Entire Cohort | Posted | Mean | Standard Deviation | millicurie | Baseline |
|
|
|
| Post-Hoc | Injection and Scan Times | Time in minutes between doses of resting Tc-99m sestamibi doses and image scanning. | Posted | Mean | Standard Deviation | minutes | Baseline |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
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| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D004603 |
| Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D028561 | Transition Elements |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
| 2-Sided |
| No |
| Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |
| 2-Sided |
| No |
| Superiority or Other |