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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

double-low scanning

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary CT angiography, Iodixanol, Diabetes, Diagnosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

traditional scanning protocol group

double-low scanning protocol group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

image quality

Compare the difference in signal-to-noise ratio (SNR),contrast-to-noise ratio (CNR) and Contrast density between the two groups.

kidney function

Compare the difference in the level of creatinine(Cr) and cystatin C in serum between the two groups.

Full Information

NCT ID

NCT04342455

First Posted

September 5, 2018

Last Updated

April 8, 2020

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Yangtze River Pharmaceutical Group Co., Ltd., Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04342455

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 7, 2018 (Actual)

Primary Completion Date

September 15, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Yangtze River Pharmaceutical Group Co., Ltd., Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary CT angiography, Iodixanol, Diabetes, Diagnosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Masking Description

This study belongs to a diagnostic test of CT angiography . All participants use the same contrast agent. The interventions on the two groups are different in scanning protocol of CTA. The examinees and image readers are blind, and the scanning technician is unblinded.

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

traditional scanning protocol group

Arm Type

No Intervention

Arm Description

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.

Arm Title

double-low scanning protocol group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

double-low scanning

Intervention Description

a CT angiography protocol with low radiation and contrast agent exposure

Primary Outcome Measure Information:

Title

diagnosis accuracy (including sensitivity,specificity of the low-dose radiation and contrast agent exposure protocol for coronary CTA)

Description

Comparing with invasive coronary angiography,if the low-dose radiation and contrast agent exposure protocol for coronary CTA can detect significant（>50%）stenosis.

Time Frame

three years

Secondary Outcome Measure Information:

Title

image quality

Description

Time Frame

three years

Title

image quality

Description

Compare the difference in signal-to-noise ratio (SNR),contrast-to-noise ratio (CNR) and Contrast density between the two groups.

Time Frame

three years

Title

kidney function

Description

Compare the difference in the level of creatinine(Cr) and cystatin C in serum between the two groups.

Time Frame

three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Zhijie

Phone

+86 137 7204 1327

jianzhijie80@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yang Jian

Phone

+86 189 9123 2396

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yang Jian

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affiliated Hospital of Xi'an Jiaotong University

City

Xi'an

State/Province

Shaanxi

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Yang, Ph.D.,M.D.

Phone

+8618991232396

cjr.yangjian@vip.163.com

12. IPD Sharing Statement

Learn more about this trial

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

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