A Low-dose Radiation and Contrast Agent Exposure Protocol for Coronary CTA in Diabetic Patients

April 8, 2020 updated by: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yang Jian
  • Phone Number: +86 189 9123 2396

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: traditional scanning protocol group
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.
Experimental: double-low scanning protocol group
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).
Other: double-low scanning
a CT angiography protocol with low radiation and contrast agent exposure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
image quality
Time Frame: three years
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.
three years
image quality
Time Frame: three years
Compare the difference in signal-to-noise ratio (SNR),contrast-to-noise ratio (CNR) and Contrast density between the two groups.
three years
kidney function
Time Frame: three years
Compare the difference in the level of creatinine(Cr) and cystatin C in serum between the two groups.
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fudan University
Yangtze River Pharmaceutical Group Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yang Jian, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2018LSY-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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