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| ID | Type | Description | Link |
|---|---|---|---|
| 593F | Other Identifier | RDRC | |
| NCT00850473 | Registry Identifier | PET/CT study in the Diagnosis of Coronary Plaque |
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Sub-investigator left the university
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This study is being done to determine if a picture taking test of the heart, positron emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in the heart arteries that lead to heart attacks when compared to the standard of heart catheterization.
Heart catheterization, in which a thin plastic tube, or catheter, is placed into an artery in the arm or leg and advanced into the heart arteries, is the procedure that you and your doctor have decided to pursue to look for heart artery blockages. It is being performed as part of your standard care and not for research purposes. The research procedure (cardiac PET/CT), which will be performed at a later date is a combination of heart CT (a test that involves the use of x-rays to identify heart artery blockages) and heart PET (an imaging test that uses a radioactive drug to look at how the heart uses fuel (sugar and fats) These tests will be combined (PET/CT) to look for the presence and type of blockage in your heart arteries.
It is important to develop a test that can determine if and what type of blockage you have in your heart arteries as the presence and type of heart artery blockage is a very important predictor of heart attack and death from heart attack.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positron Emitting Image | Experimental | Patient will have a PET/CT imaging study to determine cardiac stenosis, F-18 FDG and heparin/intralipid infusion and Contrast Dye.will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT | Diagnostic Test | Patient will have one imaging modality - a Positron Emitting Tomography CT which includes F-18 FDG and heparin/intralipid infusion and Contrast Dye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clear Anatomical Landmarks Confirmed by CT | Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography. | During PET CT scan, an average of 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rao, MD | Washington University in St. Louis Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Imaging Laboratory | St Louis | Missouri | 63110 | United States |
there is no plan to make individual participant data available to other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Positron Emitting Image, F-18 FDG, Contrast Dye | Patient will have a PET/CT imaging study to determine cardiac stenosis, patient will have an injection of F18 FDG to determine the metabolic uptake of the radio-isotope, patient will have contrast dye injected to better visualize the coronary arteries. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Positron Emitting Image, F18 FDG, Contrast Dye | Patient will have a PET/CT imaging study to determine cardiac stenosis, patient will have an injection of F18 FDG to determine the metabolic uptake of the radio-isotope, patient will have contrast dye injected to better visualize the coronary arteries. |
| 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 | Number of Participants With Clear Anatomical Landmarks Confirmed by CT | Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography. | Posted | Count of Participants | Participants | During PET CT scan, an average of 2 hours |
|
|
During PET CT scan an average of 2 hours
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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 | Positron Emitting Image, F18 FDG, Contrast Dye | PET/CT: Patient will have a Positron Emitting Tomography imaging Patient will have an injection of F-18-FDG to determine the metabolic uptake of the radioisotope Contrast Dye: Patient will be injected with contrast dye to better visualize the coronary arteries Heparin/intralipid infusion: Patient will be injected with heparin/intralipid infusion for backgroud myocardial uptake |
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There were no limitations or caveats
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory | Washington University School of Medicine | 314-747-3877 | groplerr@mir.wustl.edu |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Participants |
|
| 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 | Count of Participants | Participants |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |