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| Name | Class |
|---|---|
| Yangtze River Pharmaceutical Group Co., Ltd. | INDUSTRY |
| Fudan University | OTHER |
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To assess diagnostic accuracy,image quality and renal safety of a double low-dose coronary CTA protocol at coronary artery evaluation in patients with diabetes by using invasive coronary angiography(ICA) as the reference method and to compare the results with those obtained traditional dose protocol. The study will randomly include about 400 consecutive participants aged 18 to 80 years old who had been diagnosed with diabetes and suspected coronary artery disease.All participants undergo ICA and coronary CT angiography performed with a whole-heart CT scan.Coronary segment interpretability,image quality based on a four-point Likert scale,blood indicators of renal function will be accessed between double low-dose CTA protocol and traditional CTA protocol. Investigators hypothesize that an individualized coronary CTA protocol that appropriately reduces radiation dose and contrast dose does not affect image quality and diagnostic accuracy, and can reduce the risk of kidney damage in high-risk patients.
The study has been approved by the local ethics committee and allparticipants will be provided written informed consent. Iodixanol 320 mg/ml is injected followed by 30 ml of saline solution.In the test group,the tube voltage,contrast agent volume and flow rate are adapted to cardiac ejection fraction(EF) and body mass index(BMI)according to the pretest. participants in the contract group are injected 50 ml contrast agent with the flow rate of 5 ml/s in tube voltage of 120 kVp. All participants are scanned in automatic tube current.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| traditional scanning protocol group | No Intervention | In coronary CTA examination,each subject will be injected 50 ml contrast agent (Iodixanol 320) with the flow rate of 5 ml/s in tube voltage of 120 kVp. | |
| double-low scanning protocol group | Experimental | In coronary CTA examination,the tube voltage(70,80,100kVp),contrast agent(Iodixanol 320) volume and flow rate of each subject are adapted to his or her cardiac ejection fraction(EF) and body mass index(BMI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| double-low scanning | Other | a CT angiography protocol with low radiation and contrast agent exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| diagnosis accuracy (including sensitivity,specificity of the low-dose radiation and contrast agent exposure protocol for coronary CTA) | Comparing with invasive coronary angiography,if the low-dose radiation and contrast agent exposure protocol for coronary CTA can detect significant(>50%)stenosis. | three years |
| Measure | Description | Time Frame |
|---|---|---|
| image quality | two independent blinded readers semi-quantitatively the image quality.Compare the difference in image quality score between the the low-dose radiation and contrast agent exposure protocol and the traditional protocol. | three years |
| image quality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhijie | Contact | +86 137 7204 1327 | jianzhijie80@126.com | |
| Yang Jian | Contact | +86 189 9123 2396 |
| Name | Affiliation | Role |
|---|---|---|
| Yang Jian | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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All subjects undergo coronary CTA and invasive coronary angiography (ICA), but coronary CTA examinees are divided into two groups performing different scanning and contrast protocols.
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This study belongs to a diagnostic test of CT angiography . All participants use the same contrast agent. The interventions on the two groups are different in scanning protocol of CTA. The examinees and image readers are blind, and the scanning technician is unblinded.
Compare the difference in signal-to-noise ratio (SNR),contrast-to-noise ratio (CNR) and Contrast density between the two groups. |
| three years |
| kidney function | Compare the difference in the level of creatinine(Cr) and cystatin C in serum between the two groups. | three years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |