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

NCT ID: NCT04342455

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-07
• Study Completion Date: 2020-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

double-low scanning

Intervention Type: OTHER

a CT angiography protocol with low radiation and contrast agent exposure

Interventions

double-low scanning

a CT angiography protocol with low radiation and contrast agent exposure

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangtze River Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Jian

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Zhijie

Role: CONTACT

jianzhijie80@126.com

+86 137 7204 1327

Yang Jian

Role: CONTACT

+86 189 9123 2396

Facility Contacts

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

Role: primary

cjr.yangjian@vip.163.com

+8618991232396

Other Identifiers

XJTU1AF2018LSY-23

Identifier Type: -

Identifier Source: org_study_id