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Contrast Enhancement on Coronary Computed Tomographic Angiography

NCT02462044 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-01-05

No results posted yet for this study

Summary

Computed tomographic angiography (CTA) is an important prognostic tool with regard to the detection of coronary artery stenoses. Both iodine delivery rate (IDR; the amount of iodine delivered to the patient per second) and iodine concentration are decisive factors in the opacification of arterial vessels.

There remains to be some debate in the literature about whether the use of high iodine concentration contrast media is beneficial compared to lower iodine concentrations.

To date, there have not been any studies comparing intracoronary attenuation using concentrated contrast media lower than 300 mg I/ml at coronary CTA. For a reliable comparison of CM with different iodine concentrations, adapted injection protocols insuring an identical IDR (in g iodine per second) are mandatory. The investigators hypothesize that usage of lower iodine concentrations, while maintaining identical IDR and total iodine load, will result in comparable diagnostical intra-vascular attenuation in CTA.

Conditions

  • Coronary Artery Disease
  • Coronary Stenosis

Interventions

DRUG

240 mg Iodine

DRUG

300 mg Iodine

DRUG

370 mg Iodine

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • Netherlands

Study Locations

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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 NCT02462044 on ClinicalTrials.gov