Clinical trial NCT02549794: Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: low concentration contrast agent
Low dose contrast agent
computed tomography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography
timeFrame: 7 days
Secondary outcomes:
measure: Qualitative evaluation of image quality of coronary artery
timeFrame: 7 days
measure: Quantitative analysis of image quality using measuring HU
timeFrame: 7 days
measure: Diagnostic accuracy of coronary CT angiography compared to invasive coronary angiography
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
citation: Im DJ, Kim YH, Choo KS, Kang JW, Jung JI, Won Y, Kim HR, Chung MH, Han K, Choi BW. Comparison of coronary computed tomography angiography image quality with high- and low-concentration contrast agents (CONCENTRATE): study protocol for a randomized controlled trial. Trials. 2016 Jul 15;17(1):315. doi: 10.1186/s13063-016-1441-y.