Coronary Artery DiseaseNCT04342455
A Low-dose Radiation and Contrast Agent Exposure Protocol for Coronary CTA in Diabetic Patients
A study testing double-low scanning in people with Coronary Artery Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- double-low scanning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2018to 31 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years old and ≤ 80 years old;
- patients who have previously diagnosed diabetes;
- patients with suspected coronary artery disease and undergoing coronary CT angiography (CTA);
- Subjects are fully informed and provided written informed consent.
Who cannot join
- The exclusion criteria are pregnancy and lactation women or recent birth planners
- patients with Iodine contrast agent contraindications (such as a history of severe allergy history with iodine contrast agents, hyperthyroidism, etc.)
- patients with chronic kidney disease (Phase 4-5, eGFR <30 ml/min/1.73 m2)
- patients who have undergone coronary stent implantation or coronary artery bypass surgery
- patients who have received iodine contrast-related tests within 24 hours
- participated in other clinical trials within 3 months
- other circumstances that the investigator believes are not suitable for participation in the trial
Trial locations and contacts
1 site in 1 country.
Yang Jian contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Jian Yang, Ph.D.,M.D., +8618991232396, cjr.yangjian@vip.163.com
About this study
Official title: Evaluation the Diagnostic Efficacy of a Low-dose Radiation and Contrast Agent Exposure Protocol for Coronary Computed Tomography Angiography(CTA)on Coronary Artery Disease in Diabetic Patients
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- double-low scanning
- Keywords
- Coronary CT angiography, Iodixanol, Diabetes, Diagnosis
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double-low scanningOther
a CT angiography protocol with low radiation and contrast agent exposure
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: double-low scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three years
Secondary outcomes (3)
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.
Measured: three years
image quality
Compare the difference in signal-to-noise ratio (SNR),contrast-to-noise ratio (CNR) and Contrast density between the two groups.
Measured: three years
kidney function
Compare the difference in the level of creatinine(Cr) and cystatin C in serum between the two groups.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start7 Oct 2018
- Primary completion15 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Yangtze River Pharmaceutical Group Co., Ltd., Fudan University
- Responsible party
- Sponsor
- Investigators
- Yang Jian, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342455
- Sponsor's protocol ID
- XJTU1AF2018LSY-23
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Diagnostic Efficacy of a Low-dose Radiation and Contrast Agent Exposure Protocol for Coronary Computed Tomography Angiography(CTA)on Coronary Artery Disease in Diabetic Patients
- ClinicalTrials.gov ID
- NCT04342455
- Acronym / sponsor ID
- XJTU1AF2018LSY-23
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary CT angiography, Iodixanol, Diabetes, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Yangtze River Pharmaceutical Group Co., Ltd., Fudan University
- Study start
- 7 Oct 2018 (actual)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Apr 2020 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: double-low scanningIn 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years old and ≤ 80 years old;
- patients who have previously diagnosed diabetes;
- patients with suspected coronary artery disease and undergoing coronary CT angiography (CTA);
- Subjects are fully informed and provided written informed consent.
Key exclusion criteria (7 listed)
- The exclusion criteria are pregnancy and lactation women or recent birth planners
- patients with Iodine contrast agent contraindications (such as a history of severe allergy history with iodine contrast agents, hyperthyroidism, etc.)
- patients with chronic kidney disease (Phase 4-5, eGFR <30 ml/min/1.73 m2)
- patients who have undergone coronary stent implantation or coronary artery bypass surgery
- patients who have received iodine contrast-related tests within 24 hours
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 |
|---|---|---|
| double-low scanninga CT angiography protocol with low radiation and contrast agent exposure | Other | double-low scanning protocol group |
Primary outcome
diagnosis accuracy (including sensitivity,specificity of the low-dose radiation and contrast agent exposure protocol for coronary CTA)
Time frame: three years
Comparing with invasive coronary angiography,if the low-dose radiation and contrast agent exposure protocol for coronary CTA can detect significant（>50%）stenosis.
3 secondary outcomes
image quality
Time frame: three years
image quality
Time frame: three years
kidney function
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
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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.
Yang Jian contact
Yang Jian principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double-low scanning in people with Coronary Artery Disease, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Apr 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhijie (+86 137 7204 1327, jianzhijie80@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis accuracy (including sensitivity,specificity of the low-dose radiation and contrast agent exposure protocol for coronary CTA) (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2020.