Coronary Artery DiseaseNCT02549794
Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)
A study testing CT angiography with high concentration contrast agent, CT angiography with low concentration contrast agent (320) and CT angiography with low concentration contrast agent (270) in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT angiography with high concentration contrast agent, CT angiography with low concentration contrast agent (320) and CT angiography with low concentration contrast agent (270)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2015to 27 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 20 years old
- Subject who had requested a coronary CT angiography as per a clinical disease
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- CT angiography with high concentration contrast agent, CT angiography with low concentration contrast agent (320), CT angiography with low concentration contrast agent (270)
- Keywords
- low concentration contrast agent, Low dose contrast agent, computed tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT angiography with high concentration contrast agentProcedure or surgery
Standard concentration of iodine contrast agent for CT
CT angiography with low concentration contrast agent (320)Procedure or surgery
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)Procedure or surgery
Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.
| Study group | Role | What they receive |
|---|---|---|
| High concentration (370) | Active comparator | CT angiography with hign concentration iodine contrast agent of 370 mg iodine/ml Receives: Procedure: CT angiography with high concentration contrast agent |
| Low concentration (320) | Experimental | CT angiography with low concentration iodine contrast agent of 320 mg iodine/ml Receives: Procedure: CT angiography with low concentration contrast agent (320) |
| Low concentration (270) | Experimental | CT angiography with low concentration iodine contrast agent of 270 mg iodine/ml Receives: Procedure: CT angiography with low concentration contrast agent (270) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography
Measured: 7 days
Secondary outcomes (3)
Qualitative evaluation of image quality of coronary artery
Measurement of evaluable segment with 4 point grading system as visual assessment
Measured: 7 days
Quantitative analysis of image quality using measuring HU
Measurement of HU (Hounsfield unit) of myocardium during adenosine stress test in static perfusion CT
Measured: 7 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start10 Jul 2015
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549794
- Sponsor's protocol ID
- 4-2015-0173
- Status last verified
- Jan 2019
- First submitted
- 16 Aug 2015
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27418333
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)
- ClinicalTrials.gov ID
- NCT02549794
- Acronym / sponsor ID
- 4-2015-0173
- Conditions
- Coronary Artery Disease
- Keywords
- low concentration contrast agent, Low dose contrast agent, computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Jul 2015
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High concentration (370) | Active comparator | Procedure: CT angiography with high concentration contrast agentCT angiography with hign concentration iodine contrast agent of 370 mg iodine/ml |
| Low concentration (320) | Experimental | Procedure: CT angiography with low concentration contrast agent (320)CT angiography with low concentration iodine contrast agent of 320 mg iodine/ml |
| Low concentration (270) | Experimental | Procedure: CT angiography with low concentration contrast agent (270)CT angiography with low concentration iodine contrast agent of 270 mg iodine/ml |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults at least 20 years old
- Subject who had requested a coronary CT angiography as per a clinical disease
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT angiography with high concentration contrast agentStandard concentration of iodine contrast agent for CT | Procedure or surgery | High concentration (370) |
| 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. | Procedure or surgery | Low concentration (320) |
| 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. | Procedure or surgery | Low concentration (270) |
Primary outcome
Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography
Time frame: 7 days
3 secondary outcomes
Qualitative evaluation of image quality of coronary artery
Time frame: 7 days
Quantitative analysis of image quality using measuring HU
Time frame: 7 days
Diagnostic accuracy of coronary CT angiography compared to invasive coronary angiography
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 27418333Im 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT angiography with high concentration contrast agent, CT angiography with low concentration contrast agent (320) and CT angiography with low concentration contrast agent (270) in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.