Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2015
CompletedFirst Submitted
Initial submission to the registry
August 16, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2017
CompletedJanuary 29, 2019
January 1, 2019
1.7 years
August 16, 2015
January 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography
7 days
Secondary Outcomes (3)
Qualitative evaluation of image quality of coronary artery
7 days
Quantitative analysis of image quality using measuring HU
7 days
Diagnostic accuracy of coronary CT angiography compared to invasive coronary angiography
7 days
Study Arms (3)
High concentration (370)
ACTIVE COMPARATORCT angiography with hign concentration iodine contrast agent of 370 mg iodine/ml
Low concentration (320)
EXPERIMENTALCT angiography with low concentration iodine contrast agent of 320 mg iodine/ml
Low concentration (270)
EXPERIMENTALCT angiography with low concentration iodine contrast agent of 270 mg iodine/ml
Interventions
Standard concentration of iodine contrast agent for CT
Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.
Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.
Eligibility Criteria
You may qualify if:
- Adults at least 20 years old
- Subject who had requested a coronary CT angiography as per a clinical disease
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance hospital
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 27418333DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2015
First Posted
September 15, 2015
Study Start
July 10, 2015
Primary Completion
March 27, 2017
Study Completion
March 27, 2017
Last Updated
January 29, 2019
Record last verified: 2019-01