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

NCT04342455 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-04-13

No results posted yet for this study

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

Interventions

OTHER

double-low scanning

a CT angiography protocol with low radiation and contrast agent exposure

Sponsors & Collaborators

  • Yangtze River Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • Fudan University

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Yang Jian · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-07
Primary Completion
2020-09-15
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342455 on ClinicalTrials.gov