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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most advantageous in obtaining information on myocardial blood flow and volume. However, dynamic CT perfusion technique involves higher radiation dose than static CT techniques. Patients have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If patients cannot hold their breath, anterior or inferior myocardium might be excluded due to limited scan coverage of a 128-slice dual-source CT scanner.
Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation exposure, but also make patients more comfortable. Therefore, the investigators intended to propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy of a modified scan protocol with the current scan protocol.
The aim of this study is to compare the diagnostic performance of adenosine-stress dynamic myocardial CT perfusion using a reduced dynamic scan duration with perfusion protocol of 30-second scan duration for the detection of myocardial perfusion defect and significant coronary artery stenosis.
This trial is a single center, prospective, randomized trial designed to compare diagnostic performances and radiation doses between two protocols with 30-second or 21-second dynamic scan durations. A total of 120 symptomatic patients will be randomized to dynamic CT perfusion protocols with 30-second or 21-second scan duration. They will also undergo 1.5-T MRI and invasive coronary angiography as reference standards for the assessment of myocardial perfusion and coronary artery stenosis. The primary end point of the study is to compare diagnostic performances between two CT protocols of dynamic CT perfusion. The secondary endpoint of this study is to compare radiation doses and image qualities of two scan protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myocardial CT perfusion (21-second) | Experimental | A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 21-second scan duration. |
|
| Myocardial CT perfusion (30-second) | Active Comparator | A total of 60 symptomatic patients will be randomized to dynamic CT perfusion protocol with 30-second scan duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myocardial CT perfusion | Procedure | Adenosine-stress dynamic myocardial CT perfusion using 128-slice dual-source CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the curve) of CT perfusion for detection of perfusion defects : 30-second scanning protocol versus 21-second scanning protocol | There were no significant differences in the diagnostic performances between two CTP protocols with different scan duration. | When all randomized patients underwent CT scanning (A total of 120 symptomatic patients will be randomized to dynamic CT perfusion protocols with 30-second or 21-second scan duration.) |
| Measure | Description | Time Frame |
|---|---|---|
| Effective radiation dose for each component of the CT examination is calculated as the product of the dose-length product multiplied by a conversion coefficient of 0.014 (mSv/[mGycm]). | CTP with shorter scan duration resulted in a 23% reduction of radiation dose compared with 30-second scan protocol | up to 1 week after each patient underwent CT scanning |
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Inclusion Criteria:
Exclusion Criteria:
Contraindication of CT
Contraindication of MRI
Unstable or uncooperative patients
Limited life expectancy due to cancer or end-stage renal or liver disease
Evidence of severe symptomatic heart failure (NYHA Class III or IV)
Acute myocardial infarction, hypertrophic cardiomyopathy, dilated cardiomyopathy, coronary artery bypass surgery, or other cardiac surgery
Women with positive pregnancy tests
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| Name | Affiliation | Role |
|---|---|---|
| Yeon Hyeon Choe, M.D.,Ph.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |