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

January 27, 2019 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults at least 20 years old
  • Subject who had requested a coronary CT angiography as per a clinical disease

Exclusion Criteria:

  • Subject suspected as having myocardial infarction, unstable angina pectoris, coronary artery disease
  • Subject with heart attack within 40 days prior to the CT scan
  • Subject with diagnosed complicated heart anomaly
  • BMI (body mass index) > 35kg/m2
  • Serum creatinine ≥1.5mg/dl of renal insufficiency
  • Subject with pregnancy or unknown pregnancy
  • Subject with history of hypersensitivity reaction of contrast agents
  • Subject has contraindication of using nitroglycerine
  • Subject has plan to participate or enrolled in other randomized clinical trial for cardiovascular disease.
  • Subject has contraindication of using adenosine (e.g. bronchial asthma, 2-3 degree AV block, sick sinus syndrome, SBP (systolic blood pressure) less than 90mmHg, recent prescribed history of dipyridamole, hypersensitivity of adenosine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High concentration (370)
CT angiography with hign concentration iodine contrast agent of 370 mg iodine/ml
Procedure: CT angiography with high concentration contrast agent
Standard concentration of iodine contrast agent for CT
Experimental: Low concentration (320)
CT angiography with low concentration iodine contrast agent of 320 mg iodine/ml
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.
Experimental: Low concentration (270)
CT angiography with low concentration iodine contrast agent of 270 mg iodine/ml
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess HU (Hounsfield unit) for image quality of 3 different protocol of contrast media in coronary CT angiography
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative evaluation of image quality of coronary artery
Time Frame: 7 days
Measurement of evaluable segment with 4 point grading system as visual assessment
7 days
Quantitative analysis of image quality using measuring HU
Time Frame: 7 days
Measurement of HU (Hounsfield unit) of myocardium during adenosine stress test in static perfusion CT
7 days
Diagnostic accuracy of coronary CT angiography compared to invasive coronary angiography
Time Frame: 7 days
On segment-basis analysis, sensitivity, specificity, positive negative predictive value, negative predictive value, and accuracy of CT angiography for diagnosis of presence of CAD which is defined by more than 50% diameter stenosis compared to invasive coronary angiography, will be calculated and compared between different concentration of contrast agents by means of generalized estimating equation based on binary logistic model.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 10, 2015

Primary Completion (Actual)

March 27, 2017

Study Completion (Actual)

March 27, 2017

Study Registration Dates

First Submitted

August 16, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 27, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on CT angiography with high concentration contrast agent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe