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

NCT04342455 | Unknown

• 1 other identifier: XJTU1AF2018LSY-23
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary CT angiography; Iodixanol; Diabetes; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• image quality

  three years

• image quality

  three years

• kidney function

  three years

Study Arms (2)

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).

Other: double-low scanning

Interventions

double-low scanning OTHER

a CT angiography protocol with low radiation and contrast agent exposure

double-low scanning protocol group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Yangtze River Pharmaceutical Group Co., Ltd.: collaborator
• Fudan University: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus; Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Jian

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhijie

CONTACT

+86 137 7204 1327; jianzhijie80@126.com

Yang Jian

CONTACT

+86 189 9123 2396

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: April 13, 2020
• Study Start: October 7, 2018
• Primary Completion: September 15, 2020
• Study Completion: December 31, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-03

Locations

CN (1)