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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342455
• Other study ID #: XJTU1AF2018LSY-23
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jian Zhijie
• Phone: +86 137 7204 1327
• Email: jianzhijie80[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• double-low scanning
a CT angiography protocol with low radiation and contrast agent exposure

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Fudan University, Yangtze River Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	three years
Secondary	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.	three years
Secondary	image quality	Compare the difference in signal-to-noise ratio (SNR),contrast-to-noise ratio (CNR) and Contrast density between the two groups.	three years
Secondary	kidney function	Compare the difference in the level of creatinine(Cr) and cystatin C in serum between the two groups.	three years