Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549794
• Other study ID #: 4-2015-0173
• Status: Completed
• Phase: N/A
• Start date: July 10, 2015
• Est. completion date: March 27, 2017

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to CT technology development, cardiac CT is very useful examination as noninvasive examination and the accuracy in locating lesions has increased to 95%. Specifically, cardiac CT has been performing a gateway role in reducing invasive cardiac angiography implemented solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac angiography. However, cardiac CT also comes with the disadvantage that patients cannot avoid being exposed to radiation, so there has been much effort in appealing to reduce exposed radiation dose. Of these methods, the most effective is the method of repeatedly reconstitution by way of synchronized prospective ECG while using low tube-based potential. According to recent studies, the SNR(Signal Noise Ratio) and CNR(Contrast Noise Ratio) values representing image quality have been higher compared to the combined method of image reconstruction by makeshift filtered back projection and condition of image acquisition by patient BMI. Also, the administered amount of contrast agent can be reduced for achieving the same contrast effect due to the advantage of the increased effect of contrast enhancement by using low tube voltage. Therefore, the efficacy studies of using low concentration of contrast agents in conditions of using low tube voltage are being processed.

This study intends to prove that image quality does not deteriorate by suitable image reconstruction method with low concentration contrast agent compared to the combined method of the makeshift filtered back projection image reconstruction method and the conditions of image acquisition according to BMI with general amount of contrast agent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 27, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adults at least 20 years old

• Subject who had requested a coronary CT angiography as per a clinical disease

Exclusion Criteria:

• Subject suspected as having myocardial infarction, unstable angina pectoris, coronary artery disease

• Subject with heart attack within 40 days prior to the CT scan

• Subject with diagnosed complicated heart anomaly

• BMI (body mass index) > 35kg/m2

• Serum creatinine =1.5mg/dl of renal insufficiency

• Subject with pregnancy or unknown pregnancy

• Subject with history of hypersensitivity reaction of contrast agents

• Subject has contraindication of using nitroglycerine

• Subject has plan to participate or enrolled in other randomized clinical trial for cardiovascular disease.

• Subject has contraindication of using adenosine (e.g. bronchial asthma, 2-3 degree AV block, sick sinus syndrome, SBP (systolic blood pressure) less than 90mmHg, recent prescribed history of dipyridamole, hypersensitivity of adenosine)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• CT angiography with high concentration contrast agent
Standard concentration of iodine contrast agent for CT
• CT angiography with low concentration contrast agent (320)
Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.
• CT angiography with low concentration contrast agent (270)
Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography		7 days
Secondary	Qualitative evaluation of image quality of coronary artery	Measurement of evaluable segment with 4 point grading system as visual assessment	7 days
Secondary	Quantitative analysis of image quality using measuring HU	Measurement of HU (Hounsfield unit) of myocardium during adenosine stress test in static perfusion CT	7 days
Secondary	Diagnostic accuracy of coronary CT angiography compared to invasive coronary angiography	On segment-basis analysis, sensitivity, specificity, positive negative predictive value, negative predictive value, and accuracy of CT angiography for diagnosis of presence of CAD which is defined by more than 50% diameter stenosis compared to invasive coronary angiography, will be calculated and compared between different concentration of contrast agents by means of generalized estimating equation based on binary logistic model.	7 days