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Comparison of Image Quality of Coronary Computed Tomography Angiography bEtweeN High concenTRATion and Low concEntration Contrast Agents(CONCENTRATE Trial)

NCT02549794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-01-29

No results posted yet for this study

Summary

According to CT technology development, cardiac CT is very useful examination as noninvasive examination and the accuracy in locating lesions has increased to 95%. Specifically, cardiac CT has been performing a gateway role in reducing invasive cardiac angiography implemented solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac angiography. However, cardiac CT also comes with the disadvantage that patients cannot avoid being exposed to radiation, so there has been much effort in appealing to reduce exposed radiation dose. Of these methods, the most effective is the method of repeatedly reconstitution by way of synchronized prospective ECG while using low tube-based potential. According to recent studies, the SNR(Signal Noise Ratio) and CNR(Contrast Noise Ratio) values representing image quality have been higher compared to the combined method of image reconstruction by makeshift filtered back projection and condition of image acquisition by patient BMI. Also, the administered amount of contrast agent can be reduced for achieving the same contrast effect due to the advantage of the increased effect of contrast enhancement by using low tube voltage. Therefore, the efficacy studies of using low concentration of contrast agents in conditions of using low tube voltage are being processed.

This study intends to prove that image quality does not deteriorate by suitable image reconstruction method with low concentration contrast agent compared to the combined method of the makeshift filtered back projection image reconstruction method and the conditions of image acquisition according to BMI with general amount of contrast agent.

Conditions

Interventions

PROCEDURE

CT angiography with high concentration contrast agent

Standard concentration of iodine contrast agent for CT

PROCEDURE

CT angiography with low concentration contrast agent (320)

Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.

PROCEDURE

CT angiography with low concentration contrast agent (270)

Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-10
Primary Completion
2017-03-27
Completion
2017-03-27

Countries

  • South Korea

Study Locations

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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 NCT02549794 on ClinicalTrials.gov