Diagnostic Accuracy of Cardiac CT Perfusion Compared to PET Imaging
| Tracking Information | |||||
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| First Received Date ICMJE | September 9, 2011 | ||||
| Last Updated Date | September 13, 2011 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Diagnostic accuracy measures of cardiac CT perfusion techniques [ Time Frame: 1 month ] [ Designated as safety issue: No ] Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the curve [ROC AUC]. The highest ROC AUC will be considered the best diagnostic performance and will be compared statisically using the c-statistic. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01434043 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Diagnostic Accuracy of Cardiac CT Perfusion Compared to PET Imaging | ||||
| Official Title ICMJE | Diagnostic Accuracy of Cardiac CT Perfusion Compared to PET Imaging | ||||
| Brief Summary | This purpose of this research project is to test the diagnostic accuracy (i.e., sensitivity, specificity, positive and negative predictive value, and receiver operator curve area under the curve) of cardiac computed tomography (CT) perfusion as compared to the best non-invasive test of blood flow -- cardiac positron emission transmission (PET) perfusion imaging. The primary outcome of the study is to determine the CT perfusion technique with the highest overall diagnostic accuracy measured by the highest area under the receiver operator curve. The investigators will test 4 different CT perfusion techniques. (A) Qualitative, visual inspection of the contrast-enhanced CT images (B) Enhanced voxel distribution analysis (C) Rate of myocardial contrast enhancement analysis (D) Quantitative heart blood flow using a distributed 2-region analysis A second aim is to reduce the radiation dose needed to maintain CT perfusion diagnostic accuracy. Using the CT perfusion data, the investigators will model the minimal number of cardiac cycle radiation exposures needed to keep the diagnostic accuracy similar to the full data set. A third aim is to test the incremental diagnostic accuracy of CT angiography plus CT perfusion to identify regions of low blood flow as compared to PET perfusion alone. |
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| Detailed Description | Chest pain and other symptoms can occur as a result of blockages in the arteries that supply the heart; these arteries are called the "coronary arteries". Blockages in the coronary arteries may decrease blood flow and oxygen delivery to the heart muscle, causing chest pain or other "anginal" symptoms. Coronary angiography is a commonly used test to visualize coronary artery disease or blockages but may not provide all the answers physicians need to assess patients with symptoms like chest pain. Two options for coronary angiography exist, invasive angiography and cardiac computed tomography angiography (CCTA). CCTA is completed by injecting contrast into a peripheral vein (not an artery) and then imaging when the coronary arteries fill with contrast. The imaged coronary arteries may be blocked partially, completely or not at all. While a blockage that occludes greater than 70% of an artery is highly correlated with chest pain or other anginal symptoms, occlusions of 40% or more may or may not decrease heart blood flow. Often multiple imaging studies are needed to evaluate whether blood flow is decreased in the setting of partial coronary artery blockages including non-invasive heart imaging to assess heart blood flow. One type of nuclear imaging is termed positron emission tomography (PET). In order to differentiate blockages that have poor heart perfusion with activity, nuclear PET images are taken at rest, when flow should be normal, and then repeated after the investigators "stress" the heart with medications. If blood flow is decreased during stress, a "defect" on the PET images is seen. An alternative, non-invasive technique to test for heart blood flow/perfusion to to measure heart blood flow as computed tomography (CT) contrast goes in and comes out. Preliminary studies in animals and humans to assess heart blood flow/perfusion using contrast-enhanced cardiac CT have been promising, but further work is needed. Combining CCTA with CT blood flow/perfusion measurements in the same setting could lead to a single, accurate diagnostic test that measures coronary artery blockage as well as blood flow. One limitation of CT imaging is the amount of radiation that can be given. The CCTA radiation dose is currently less than both nuclear PET imaging and invasive coronary angiography. However, if CT blood flow imaging is added to routine CCTA to assess heart perfusion and coronary blockages in one test, the radiation dose may be higher. The primary purpose of this research project is to test the diagnostic accuracy of various cardiac CT perfusion techniques as compared to the best non-invasive test of blood flow, cardiac PET perfusion imaging. The investigators goal is to use the least amount of radiation to achieve a high diagnostic accuracy for CCTA as well as CT blood flow/perfusion. The investigators goal is to have CT heart blood flow/perfusion radiation doses that are the same or less than nuclear blood flow imaging. The investigators have estimated that they need as few as 4 low radiation dose images of the heart to allow accurate heart blood flow measurement. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Adults with suspected or known myocardial ischemia |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Myocardial ischemia patients | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01434043 | ||||
| Other Study ID Numbers ICMJE | 40326-B | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kelley Branch, University of Washington | ||||
| Study Sponsor ICMJE | University of Washington | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Washington | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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